Safety in the Spine Operating Theatre

Key points

Radiation

Use time, distance and shielding: keep fluoroscopy time short, stand as far from the beam as the procedure allows, and use ceiling, table and personal shielding. (IAEA RPOP, 10 Pearls: Radiation protection of staff in fluoroscopy)
Wear personal dosimeters as required; the IAEA advises one under the apron and one outside at neck or eye level, and Switzerland requires an over-apron dosimeter for some staff close to the patient. (IAEA RPOP 10 Pearls; BAG Augenlinsendosis und Doppeldosimetrie)
The EU Basic Safety Standards set an occupational eye-lens dose limit of 20 mSv in a single year (or 100 mSv over five years, maximum 50 mSv in one year); the UK (IRR17), Germany (StrlSchG) and Switzerland apply the same 20 mSv annual figure. (Council Directive 2013/59/Euratom, Art. 9(3)(a))
Keep hands out of the primary beam and, where possible, have the X-ray tube under the table and stand on the image-receptor side. (IAEA RPOP, 10 Pearls)

Sharps and stab injuries

Report every sharps injury promptly; employers must record and investigate it, arrange immediate medical advice where infection exposure is possible, and offer post-exposure treatment and counselling. (Health and Safety (Sharp Instruments in Healthcare) Regulations 2013, reg. 7; Directive 2010/32/EU)
In the UK, employers must avoid medical sharps or use safer sharps so far as reasonably practicable, and needles must not be recapped unless a risk assessment shows a need and a device controls the risk. (Health and Safety (Sharp Instruments in Healthcare) Regulations 2013, reg. 5)
Double gloving substantially reduces perforations of the inner glove compared with single gloves (moderate-quality evidence). (Cochrane review CD009573 (Mischke et al., 2014))
Pass sharps through a neutral zone (hands-free technique) rather than hand to hand, and consider blunt-tip needles for fascia and muscle closure. (American College of Surgeons, Revised Statement on Sharps Safety (2016))

Splashes

Wear eye/face protection whenever splashing or spraying of blood or body fluids is anticipated; ordinary prescription glasses do not count as eye protection. (ARHAI Scotland, Eye/Face Protection literature review (2025))

Equipment

The makers of radiation protection gear and of splash protection are listed below. For operating tables, head fixation and prone positioning, imaging, navigation and robotics, microscopes and everything else in a spine theatre, see Spine Theatre Builder. Buy through your hospital, which checks certification and fit.

Radiation protection: guidance(19)

Laws, international guidance and professional advice on protecting staff during fluoroscopy, intraoperative CT and O-arm imaging.

GuidanceInternational

ICRP Publication 117: Radiological Protection in Fluoroscopically Guided Procedures outside the Imaging Department

International Commission on Radiological Protection (ICRP)

Covers: Guidance on training, dose monitoring, shielding and pregnancy for staff and patients where fluoroscopy is used outside radiology departments, such as operating theatres.

Details

Standard stated: ICRP Publication 117 (Ann. ICRP 40(6), 2010)

Note: Full text is sold by the publisher; ICRP page gives the abstract only.

Official page →Source checked

Checked 6 Nov 2026

GuidanceInternational

ICRP Publication 139: Occupational Radiological Protection in Interventional Procedures

International Commission on Radiological Protection (ICRP)

Covers: Occupational protection in interventional procedures, including dose assessment with aprons, eye-lens exposure, extremity monitoring, protective garments and auditing unusual dose readings.

Details

Standard stated: ICRP Publication 139 (2018)

Note: Written mainly for interventional radiology and cardiology; principles apply to fluoroscopy-guided spine surgery.

Official page →Source checked

Checked 6 Nov 2026

GuidanceEU

Council Directive 2013/59/Euratom (Basic Safety Standards)

European Union (Council of the EU); summary by EU-OSHA

Covers: Sets basic safety standards against ionising radiation for workers, patients and the public; Article 9 sets an occupational equivalent-dose limit for the lens of the eye of 20 mSv in a single year (or 100 mSv over five consecutive years, maximum 50 mSv in one year, as specified in national law).

Details

Standard stated: Directive 2013/59/Euratom, Art. 9

Note: Applies through national transposition (deadline 6 February 2018); the binding text is on EUR-Lex (http://data.europa.eu/eli/dir/2013/59/2014-01-17). Article 9 wording checked on legislation.gov.uk: https://www.legislation.gov.uk/eudr/2013/59/chapter/III/section/2

Official page →Source checked

Checked 6 Nov 2026

GuidanceUK (Great Britain)

Ionising Radiations Regulations 2017 (IRR17), Schedule 3 dose limits

UK Parliament (SI 2017/1075); enforced by HSE

Covers: Occupational radiation protection regulations; Schedule 3 sets an eye-lens equivalent-dose limit for employees aged 18 or over of 20 mSv in a calendar year (or 100 mSv in five years, maximum 50 mSv in one year, under conditions approved by HSE).

Details

Standard stated: SI 2017/1075, Schedule 3

Note: Northern Ireland has separate regulations.

Official page →Source checked

Checked 6 Nov 2026

GuidanceUK (Great Britain)

Working with ionising radiation: IRR17 Approved Code of Practice and guidance (L121, 2nd edition)

Health and Safety Executive (HSE)

Covers: Approved Code of Practice helping employers, radiation protection advisers and supervisors meet IRR17 duties; free download.

Details

Standard stated: HSE L121 (2018)

Official page →Source checked

Checked 6 Nov 2026

GuidanceUK (Great Britain)

Guidance to the Ionising Radiation (Medical Exposure) Regulations 2017

Department of Health and Social Care (DHSC)

Covers: Non-binding guidance on interpreting IR(ME)R 2017 (as amended 2024), which govern patient (medical) exposures rather than staff dose.

Details

Standard stated: IR(ME)R 2017 (SI 2017/1322), guidance updated 4 September 2024

Note: Patient-protection regulations; staff protection falls under IRR17.

Official page →Source checked

Checked 6 Nov 2026

GuidanceUK

IR(ME)R: Society of Radiographers guide

Society and College of Radiographers (SoR)

Covers: Professional guide to IR(ME)R 2017 and IR(ME)R (NI) 2018 incl. 2024 amendments: duty holders, employer procedures, diagnostic reference levels and reporting of accidental or unintended exposures.

Details

Standard stated: IR(ME)R 2017; IR(ME)R (NI) 2018

Note: Covers patient exposure, not occupational dose.

Official page →Source checked

Checked 6 Nov 2026

GuidanceUK

Radiation Exposure in Theatre and Associated Risks

British Orthopaedic Association (BOA)

Covers: Introduction to occupational radiation risks for orthopaedic surgeons and theatre teams, with links to a BOA animation on reducing risk while operating with X-ray.

Details

Note: The page attributes its dose-limit figures to ICRP; check current UK legal limits in IRR17.

Official page →Source checked

Checked 6 Nov 2026

GuidanceUK

Lead Aprons: position statement

British Institute of Radiology (BIR)

Covers: Explains the move to BS EN 61331-1/-3:2014 for protective aprons, use of older aprons until worn out, and advises consulting a Radiation Protection Adviser when selecting PPE.

Details

Standard stated: BS EN 61331-1:2014; BS EN 61331-3:2014; Regulation (EU) 2016/425

Note: Dated 6 October 2017; warns that some part-lead or lead-free aprons may give less protection than labelled.

Official page →Source checked

Checked 6 Nov 2026

GuidanceGermany

Strahlenschutzgesetz (StrlSchG) § 78: Grenzwerte für beruflich exponierte Personen

Federal Republic of Germany (Bundesgesetz)

Covers: Sets occupational dose limits, including 20 mSv per calendar year for the lens of the eye (15 mSv for under-18s).

Details

Standard stated: StrlSchG § 78

Note: Detailed operational rules are in the Strahlenschutzverordnung (StrlSchV).

Official page →Source checked

Checked 6 Nov 2026

GuidanceGermany

Fachkunde-Richtlinie Medizin (FK-RL Medizin)

Bundesministerium für Umwelt, Klimaschutz, Naturschutz und nukleare Sicherheit (BMUKN)

Covers: Federal guideline on how doctors and other staff acquire and maintain the radiation-protection expertise (Fachkunde) required under § 83 StrlSchG to use ionising radiation on people.

Details

Standard stated: FK-RL Medizin, circular of 30 June 2026

Note: New guideline: Länder authorities must apply it from 1 January 2027 at the latest; it replaces earlier X-ray/medical Fachkunde guidelines. Check transition rules.

Official page →Source checked

Checked 6 Nov 2026

GuidanceSwitzerland

Dosisgrenzwerte für beruflich strahlenexponierte Personen

Bundesamt für Gesundheit (BAG)

Covers: Lists Swiss occupational dose limits under the Strahlenschutzverordnung (StSV), including an eye-lens equivalent dose of 20 mSv per year (or 100 mSv over five years, maximum 50 mSv in one year).

Details

Standard stated: Strahlenschutzverordnung (StSV, SR 814.501)

Note: The BAG page does not cite the StSV article number

Official page →Source checked

Checked 6 Nov 2026

GuidanceSwitzerland

Augenlinsendosis und Doppeldosimetrie

Bundesamt für Gesundheit (BAG)

Covers: Explains eye-lens dose monitoring and double dosimetry (a second dosimeter over the apron) for staff working close to the patient during fluoroscopy, with reporting duties for higher monthly eye-lens doses.

Details

Standard stated: StSV

Note: Page notes a revised regulation taking effect 1 March 2026; check current wording.

Official page →Source checked

Checked 6 Nov 2026

GuidanceAustria

Allgemeine Strahlenschutzverordnung 2020 (AllgStrSchV 2020)

Bundesministerium für Land- und Forstwirtschaft, Klima- und Umweltschutz, Regionen und Wasserwirtschaft (BMLUK)

Covers: Austrian ordinance under the Strahlenschutzgesetz 2020 covering radiation sources in medicine and occupational protection, including a lowered eye-lens dose limit for exposed workers.

Details

Standard stated: AllgStrSchV 2020 (BGBl. II Nr. 339/2020)

Note: The ministry page does not state the numeric eye-lens limit. Patient exposure is covered by the separate Medizinische Strahlenschutzverordnung.

Official page →Source checked

Checked 6 Nov 2026

GuidanceInternational

10 Pearls: Radiation protection of staff in fluoroscopy

International Atomic Energy Agency (IAEA), Radiation Protection of Patients (RPOP)

Covers: Poster of ten practical measures for staff in fluoroscopy: protective garments, time/distance/shielding, ceiling and table shields, hands out of the beam, positioning, dosimeters and training.

Details

Note: Written for interventional fluoroscopy in general.

Official page →Source checked

Checked 6 Nov 2026

GuidanceInternational

Radiation protection in orthopedic surgery (RPOP)

International Atomic Energy Agency (IAEA)

Covers: Introductory page on fluoroscopy use in orthopaedic and spine procedures (e.g. kyphoplasty, vertebroplasty, deformity correction) and the training gap among orthopaedic surgeons.

Details

Note: Landing page; practical staff-protection advice is in other RPOP pages.

Official page →Source checked

Checked 6 Nov 2026

GuidanceFrance

Recommendations for improving radiation protection in the operating theatre

Autorité de sûreté nucléaire et de radioprotection (ASNR, formerly ASN), France; advisory committee GPMED

Covers: Recommendations on risk management, responsibilities, training and tools for radiation protection during fluoroscopy-guided procedures in theatres using C-arms or mobile CT.

Details

Note: News notice from March 2020 (updated November 2022); the full GPMED report is linked from the page.

Official page →Source checked

Checked 6 Nov 2026

GuidanceInternational (peer-reviewed review)

Radiation safety and spine surgery: systematic review of exposure limits and methods to minimize radiation exposure

Srinivasan D, Than KD, Wang AC, et al. World Neurosurgery 2014;82(6):1337-43

Covers: Systematic review of surgeon radiation exposure in spine procedures and protective measures such as aprons, thyroid shields, positioning and pulsed fluoroscopy.

Details

Standard stated: doi:10.1016/j.wneu.2014.07.041

Note: Journal review, not a society guideline; no spine-society radiation guideline (NASS, SRS, EUROSPINE, EANS, AO Spine) was found.

Official page →Source checked

Checked 6 Nov 2026

GuidanceItaly (single-centre study)

Radiation exposure in spine surgery using an image-guided system based on intraoperative cone-beam CT: analysis of 107 consecutive cases

Costa F, Tosi G, Attuati L, et al. J Neurosurg Spine 2016;25(5):654-9

Covers: Measured staff and patient dose with O-arm cone-beam CT navigation; reports negligible operator exposure when protective garments and protocols are used.

Details

Note: Single-centre observational study; included because no official guidance specific to intraoperative CT/O-arm was found.

Official page →Source checked

Checked 6 Nov 2026

Radiation protection: aprons, glasses and shields(11)

Makers of lead and lead-free aprons, thyroid collars, radiation-protection glasses and goggles, and ceiling-mounted and mobile shields.

MakerGermany

MAVIG

MAVIG GmbH

Products: Aprons (vest/skirt, wrap-around), full-body protective clothing, X-ray protective glasses and visors, gloves, headwear, ceiling-suspended shields (Portegra2), mobile shields, table curtains, lower-body shields, storage.

Details

Standard stated: Not stated on home page

Maker's page →Source checked

Checked 6 Nov 2026

MakerUSA

INFAB

INFAB, LLC

Products: Lead and lead-free aprons, lead glasses, thyroid collars, lead gloves and caps, curtains, mobile barriers, sterile drapes.

Details

Standard stated: ISO 13485:2016, CE mark stated; glasses listed with 0.75 mm Pb lenses

Maker's page →Source checked

Checked 6 Nov 2026

MakerUSA

Burlington Medical (incl. Bar-Ray Products, Lite Tech, ProtecX)

Burlington Medical (a TIDI Products company)

Products: Frontal, wrap-around, vest/skirt and tailored aprons; thyroid collars, caps, sleeves; eyewear; patient shields.

Details

Standard stated: Aprons offered in 0.25, 0.35 and 0.5 mm lead equivalence; material said to meet 'ASTM and IEC' standards (no specific number given)

Note: bar-ray.com redirects to Burlington Medical, which states it merged with Bar-Ray Products and Lite Tech; Burlington describes itself as a TIDI Products company.

Maker's page →Source checked

Checked 6 Nov 2026

MakerUK

Rothband

WSR Medical Solutions Ltd t/a Rothband

Products: Lead and lead-free aprons, thyroid collars, X-ray glasses, radiation barriers, apron storage, patient protection, dosimetry systems.

Details

Standard stated: All aprons stated to conform to BS EN 61331-1:2014; lead equivalence confirmed at quotation

Maker's page →Source checked

Checked 6 Nov 2026

MakerUSA

Barrier Technologies

Barrier Technologies, LLC

Products: Lead and lead-free aprons, thyroid shields, leaded eyewear, radiation-protective gloves, mobile shields, table drapes, shield pads, CT shields.

Details

Standard stated: Not stated on home page

Maker's page →Source checked

Checked 6 Nov 2026

MakerUSA

Wolf X-Ray

Wolf X-Ray Corporation

Products: Aprons, lead protective eyewear, barriers, disposables, positioners and accessories.

Details

Standard stated: Not stated on home page

Note: Country from the About page (manufacturing in Rocky Mount, North Carolina): https://www.wolfxray.com/pages/about-us

Maker's page →Source checked

Checked 6 Nov 2026

MakerIndia

Kiran (Kiran Medical Systems, Trivitron Healthcare)

Trivitron Healthcare

Products: Double-sided, vest/skirt, coat, urology, dental and paediatric aprons, integrated thyroid shield models.

Details

Standard stated: Aprons stated to be tested to EN 61331-1 and relevant ASTM methods; no numeric lead equivalence on page

Maker's page →Source checked

Checked 6 Nov 2026

MakerUSA

Phillips Safety

Phillips Safety Products

Products: Radiation (lead) glasses including prescription and fit-over models, leaded side shields, radiation face masks.

Details

Standard stated: Front lenses stated as 0.75 mm Pb equivalent; no standard named

Note: Lead equivalence from the company support page: https://support.phillips-safety.com/hc/en-us/articles/17137864282771-What-level-of-protection-do-your-radiation-safety-glasses-provide

Maker's page →Source checked

Checked 6 Nov 2026

MakerGermany

Medical Index

Medical Index GmbH

Products: Front aprons, double aprons, vest/skirt sets, dental and patient protection, radiation-protection glasses, storage.

Details

Standard stated: DIN EN ISO 13688:2013, EN 61331-1:2014, EN 61331-3:2014 stated; company states ISO 9001 and ISO 13485 certification; dental aprons in 0.25, 0.35 and 0.50 mm Pb

Maker's page →Source checked

Checked 6 Nov 2026

MakerUK

Raybloc

Raybloc (X-Ray Protection) Ltd

Products: Structural and mobile shielding: operator and mobile X-ray screens, viewing windows, lead-lined doors and boards, warning lights.

Details

Standard stated: Not stated on home page

Note: Structural/room shielding rather than personal garments.

Maker's page →Source checked

Checked 6 Nov 2026

MakerUK

Wardray Premise

Wardray Premise Ltd

Products: X-ray personnel protection (screening, clothing and accessories) alongside MRI shielding.

Details

Standard stated: Not stated on home page

Note: Home page lists the category but not individual garment types.

Maker's page →Source checked

Checked 6 Nov 2026

Sharps and stab injuries: prevention and what to do(16)

The law on preventing sharps injuries, safer-sharps and hands-free passing, double gloving, and what to do after an injury.

GuidanceEU

Council Directive 2010/32/EU on prevention of sharp injuries in the hospital and healthcare sector

European Union; summary by EU-OSHA

Covers: Implements the HOSPEEM-EPSU framework agreement: risk assessment, safety-engineered devices, ban on recapping, training, and reporting and follow-up of sharps injuries for all healthcare workers.

Details

Standard stated: Directive 2010/32/EU (transposition by 11 May 2013)

Note: Applies via national law in each member state.

Official page →Source checked

Checked 6 Nov 2026

GuidanceUK (Great Britain)

Health and Safety (Sharp Instruments in Healthcare) Regulations 2013

UK Parliament (SI 2013/645); enforced by HSE

Covers: Requires employers to avoid sharps or use safer sharps where reasonably practicable, restrict recapping, provide disposal containers, training, and to record, investigate and act on sharps injuries incl. access to post-exposure prophylaxis.

Details

Standard stated: SI 2013/645, regs 5-7

Note: Northern Ireland has equivalent regulations (SR 2013/108).

Official page →Source checked

Checked 6 Nov 2026

GuidanceUK (Great Britain)

HSIS7: Health and Safety (Sharp Instruments in Healthcare) Regulations 2013 guidance

Health and Safety Executive (HSE)

Covers: Explains when the Sharps Regulations apply, with practical advice on use and disposal, training and actions after an injury.

Details

Standard stated: HSE HSIS7 (updated 21 April 2022)

Official page →Source checked

Checked 6 Nov 2026

GuidanceUK

Needlestick or sharps injuries in health and social care

Health and Safety Executive (HSE)

Covers: HSE topic pages on the risk of needlestick and sharps injuries and how to manage it.

Details

Official page →Source checked

Checked 6 Nov 2026

GuidanceGermany

TRBA 250: Biologische Arbeitsstoffe im Gesundheitsdienst und in der Wohlfahrtspflege

Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BAuA), Technical Rules for Biological Agents

Covers: German technical rule on protection against biological agents in healthcare, the main German reference for sharps-injury prevention and safe instruments.

Details

Standard stated: TRBA 250, November 2025 edition (GMBl. 2025; first amendment 14 November 2025)

Note: The BAuA page gives the title and version; the sharps-prevention content is in the rule text itself.

Official page →Source checked

Checked 6 Nov 2026

GuidanceGermany

DGUV Information 207-024: Risiko Nadelstich

Deutsche Gesetzliche Unfallversicherung (DGUV)

Covers: Practical guide to infection risks from needlestick and cut injuries and how to prevent them in daily healthcare work.

Details

Standard stated: DGUV Information 207-024 (August 2022)

Official page →Source checked

Checked 6 Nov 2026

GuidanceSwitzerland

Verhütung blutübertragbarer Infektionen im Gesundheitswesen

Suva (Swiss National Accident Insurance Fund)

Covers: Technical, organisational and personal measures against blood-borne infections (HIV, hepatitis B and C) in healthcare, incl. occupational-medicine and insurance aspects and measures after an incident.

Details

Standard stated: Suva 2869/30.D (edition 01.08.2026)

Note: This edition revises chapter 6 (measures after an incident); available in German, French and Italian.

Official page →Source checked

Checked 6 Nov 2026

GuidanceUSA

Sharps Safety Program Resources

Centers for Disease Control and Prevention (CDC)

Covers: Resource hub and workbook for designing and evaluating a sharps-injury prevention programme in healthcare facilities.

Details

Note: US guidance.

Official page →Source checked

Checked 6 Nov 2026

GuidanceUSA

Workbook for Designing, Implementing and Evaluating a Sharps Injury Prevention Program

Centers for Disease Control and Prevention (CDC)

Covers: Programme workbook; for the operating room it lists avoiding hand-to-hand passing via a basin or neutral zone and using blunt suture needles.

Details

Standard stated: CDC workbook (2008)

Note: 2008 document; still linked from CDC.

Official page →Source checked

Checked 6 Nov 2026

GuidanceUSA

Revised Statement on Sharps Safety

American College of Surgeons (ACS), Committee on Perioperative Care

Covers: Recommends double gloving, blunt-tip suture needles for fascia and muscle, the neutral zone / hands-free technique, and engineered sharps-injury-prevention devices where they do not compromise the operation.

Details

Standard stated: ACS statement, 1 October 2016

Note: Professional statement; the ACS notes limited published evidence for engineered devices in surgery.

Official page →Source checked

Checked 6 Nov 2026

GuidanceUSA

How we're eliminating sharps injuries (neutral zone)

AORN, Outpatient Surgery article

Covers: Describes setting up a neutral zone before incision, announcing each sharp, and keeping one sharp in the zone at a time.

Details

Note: Magazine article (October 2013 per URL), not an AORN guideline; the AORN Guidelines for Perioperative Practice are subscription-only.

Official page →Source checked

Checked 6 Nov 2026

GuidanceInternational

Gloves, extra gloves or special types of gloves for preventing percutaneous exposure injuries in healthcare personnel

Cochrane (Mischke C, Verbeek JH, Saarto A, et al.)

Covers: Systematic review: double gloving compared with single gloving substantially reduced inner-glove perforations (rate ratio 0.29; moderate-quality evidence).

Details

Standard stated: Cochrane Database Syst Rev 2014; CD009573.pub2

Note: Evidence comes from surgical settings; perforations are a surrogate for injury.

Official page →Source checked

Checked 6 Nov 2026

GuidanceInternational

Double gloving to reduce surgical cross-infection

Cochrane (Tanner J, Parkinson H)

Covers: Systematic review: a second pair of surgical gloves significantly reduces perforations of the innermost glove; indicator gloves detect more perforations.

Details

Standard stated: Cochrane Database Syst Rev 2006; CD003087

Note: 2006 review; no direct evidence on surgical site infection.

Official page →Source checked

Checked 6 Nov 2026

GuidanceUK

EAGA guidance on HIV post-exposure prophylaxis

Department of Health and Social Care / Expert Advisory Group on AIDS (EAGA)

Covers: UK guidance on occupational HIV post-exposure prophylaxis after needlestick and other exposures, with later supplementary updates on need, regimen and follow-up testing.

Details

Standard stated: EAGA 2008, last updated 29 April 2015

Note: No recent review date; follow local occupational-health policy.

Official page →Source checked

Checked 6 Nov 2026

GuidanceUK

Blood-borne viruses: protection of health care workers

Department of Health and Social Care (EAGA and Advisory Group on Hepatitis)

Covers: Infection-control guidance to protect clinical staff from occupational HIV, hepatitis B and C.

Details

Standard stated: 1998

Note: Published 1998 with no updates listed; treat as historical background.

Official page →Source checked

Checked 6 Nov 2026

GuidanceGermany, Austria

Deutsch-Österreichische Leitlinie zur medikamentösen Postexpositionsprophylaxe (PEP) nach HIV-Exposition

AWMF register 055/004 (S2k)

Covers: Joint German-Austrian guideline on HIV post-exposure prophylaxis, including occupational exposures such as needlestick injuries.

Details

Standard stated: AWMF 055/004, version 7.0 (2022)

Note: Planned review date was 12/2025; check AWMF for an update.

Official page →Source checked

Checked 6 Nov 2026

Splash protection: standards and guidance(10)

The European standards for eye protection, masks, gowns, drapes and gloves, and official guidance on eye and face protection.

StandardEurope

EN 166:2001 Personal eye-protection: Specifications

CEN (European Committee for Standardization)

Covers: Performance requirements for eye protectors (spectacles, goggles, face shields), incl. protection against droplets and splashes.

Details

Standard stated: EN 166:2001

Note: Standard is sold by national bodies; iTeh catalogue page used for title and scope.

Official page →Source checked

Checked 6 Nov 2026

StandardEurope

EN 14683:2019+AC:2019 Medical face masks: Requirements and test methods

CEN

Covers: Requirements for medical face masks that limit transmission of infective agents from staff to patients; Type IIR adds splash resistance.

Details

Standard stated: EN 14683:2019+AC:2019

Note: Masks for staff respiratory protection fall under EN 149, not EN 14683. Type IIR splash figure (16.0 kPa) from Kiwa test-house page: https://www.kiwa.com/en/service/testing-surgical-face-masks-en-14683/

Official page →Source checked

Checked 6 Nov 2026

StandardEurope

EN 13795-1:2019 Surgical clothing and drapes: Part 1 Surgical drapes and gowns

CEN

Covers: Performance requirements and test methods for single-use and reusable surgical gowns and drapes that limit transmission of infective agents.

Details

Standard stated: EN 13795-1:2019

Note: Defines standard and high performance levels; US equivalent classification is AAMI PB70.

Official page →Source checked

Checked 6 Nov 2026

StandardEurope / International

EN ISO 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms: Part 5 micro-organisms risks

CEN / ISO

Covers: Requirements and test methods for gloves protecting the wearer against micro-organisms.

Details

Standard stated: EN ISO 374-5:2016

Official page →Source checked

Checked 6 Nov 2026

StandardEurope / International

EN ISO 374-1:2016/A1:2018 Protective gloves: Part 1 chemical risks

CEN / ISO

Covers: Terminology and performance requirements for gloves protecting against chemical risks.

Details

Standard stated: EN ISO 374-1:2016/A1:2018

Note: Chemical protection; less directly relevant than Part 5 for blood exposure.

Official page →Source checked

Checked 6 Nov 2026

StandardEurope

EN 455 Medical gloves for single use (Parts 1-4)

CEN (via Estonian Centre for Standardisation listing)

Covers: Requirements for single-use medical gloves: freedom from holes (Part 1), physical properties (Part 2), biological evaluation (Part 3) and shelf life (Part 4).

Details

Standard stated: EN 455-1:2020+A2:2024; EN 455-2:2024; EN 455-3:2023; EN 455-4:2009

Official page →Source checked

Checked 6 Nov 2026

StandardInternational (EN 61331-3 in Europe)

IEC 61331-3:2014 Protective devices against diagnostic medical X-radiation: Part 3 protective clothing, eyewear and protective patient shields

International Electrotechnical Commission (IEC)

Covers: Requirements for X-ray protective aprons, gloves, eyewear and patient shields up to 150 kV.

Details

Standard stated: IEC 61331-3:2014 (Ed. 2.0)

Note: Radiation PPE standard; listed here for completeness alongside splash standards.

Official page →Source checked

Checked 6 Nov 2026

StandardUK (Scotland)

PPE: Eye/Face Protection literature review, executive summary

ARHAI Scotland (NHS National Services Scotland)

Covers: Recommends eye/face protection whenever splashing or spraying of blood or body fluids is anticipated; suitable types are goggles, face shields/visors, safety glasses with solid side shields and masks with integrated eye protection; prescription glasses are not eye protection.

Details

Standard stated: Version 1.0, 21 February 2025

Note: Scottish NIPCM; England's NIPCM is adapted from it (https://www.england.nhs.uk/publication/national-infection-prevention-and-control-manual/).

Official page →Source checked

Checked 6 Nov 2026

StandardUSA

Standard Precautions, Appendix A Table 4 (Isolation Precautions guideline)

Centers for Disease Control and Prevention (CDC)

Covers: Recommends mask, eye protection and face shield during procedures likely to generate splashes or sprays of blood or body fluids, and gowns when contact of clothing or skin with blood is anticipated.

Details

Standard stated: CDC, updated 27 November 2023

Note: US guidance.

Official page →Source checked

Checked 6 Nov 2026

StandardUK (Great Britain)

Personal Protective Equipment at Work (Amendment) Regulations 2022

Health and Safety Executive (HSE)

Covers: Extends employers' PPE duties (suitability assessment, free provision, maintenance, training) to limb (b) workers from 6 April 2022.

Details

Standard stated: SI 2022 amending PPE at Work Regulations 1992

Note: General workplace PPE law, not theatre-specific.

Official page →Source checked

Checked 6 Nov 2026

Splash protection: visors, helmets, masks, gowns and gloves(10)

Makers of surgical helmet systems, visors and face shields, fluid-resistant masks, gowns and gloves.

MakerUSA

Stryker personal protection systems (Flyte, T7, Steri-Shield 8)

Stryker

Products: Surgical helmets with hoods/togas, PeelAway lenses, face shields.

Details

Standard stated: Flyte EU page: togas AAMI PB70 Level 4 in critical zones, meet EN 13795; lenses meet EN 166. T7 and Steri-Shield 8: AAMI Level 4 critical zones

Note: T7: https://stryker.com/es/en/orthopaedic-instruments/products/t7.html ; Steri-Shield 8 launched 4 March 2025: https://www.stryker.com/us/en/about/news/2025/stryker-launches-steri-shield-8-personal-protection-system.html

Maker's page →Source checked

Checked 6 Nov 2026

MakerUSA

Zimmer Biomet ViVi Surgical Helmet System

Zimmer Biomet

Products: Surgical helmet system with dual-fan cooling and light.

Details

Standard stated: Not stated on page

Maker's page →Source checked

Checked 6 Nov 2026

MakerSweden

Mölnlycke BARRIER staff clothing

Mölnlycke Health Care (Mölnlycke AB)

Products: Surgical gowns, masks, headwear, isolation gowns, surgical gloves (incl. Biogel).

Details

Standard stated: Gown selection guide cites EN 13795-1:2019 (standard and high performance) and AAMI

Note: Country inferred from 'Mölnlycke AB'; gown standards from https://prepcorporate.molnlycke.com/our-knowledge/surgical-gown-selection-guide

Maker's page →Source checked

Checked 6 Nov 2026

MakerAustralia (HQ not stated on page)

Ansell GAMMEX surgical gloves

Ansell

Products: Sterile surgical gloves incl. latex-free formulations.

Details

Standard stated: Not stated on brand page

Note: Brand page does not name EN 455 or EN ISO 374-5; check product data sheets.

Maker's page →Source checked

Checked 6 Nov 2026

MakerGermany

uvex safety (health care)

uvex safety group (UVEX Arbeitsschutz GmbH)

Products: Safety spectacles, goggles, masks, gloves and protective clothing for the health care sector.

Details

Standard stated: Not stated on health-care page (links to a standards download)

Note: Distinct from the US 'Uvex by Honeywell' brand.

Maker's page →Source checked

Checked 6 Nov 2026

MakerUSA

Cardinal Health surgical gowns

Cardinal Health

Products: AAMI Level 3 and Level 4 surgical gowns (SmartGown range), cooling vests.

Details

Standard stated: AAMI Level 3 / Level 4 stated; EN 13795 not stated

Note: Canadian site; European availability not checked.

Maker's page →Source checked

Checked 6 Nov 2026

MakerUSA

HALYARD AERO SERIES surgical gowns

Owens & Minor (HALYARD brand)

Products: Surgical gowns AERO CHROME (Level 4) and AERO BLUE (Level 3).

Details

Standard stated: AAMI PB70:2012 Level 3/4; EN 13795 High Performance stated for Level 4; ASTM F1671/F1670

Maker's page →Source checked

Checked 6 Nov 2026

MakerGermany / Austria

Lohmann & Rauscher Sentinex

Lohmann & Rauscher (L&R)

Products: Surgical face masks (Classic, Sensitive, Safety, Safety Shield), theatre clothing and gowns.

Details

Standard stated: EN 14683; Sentinex Safety and Safety Shield stated as Type IIR

Note: Country not stated on page (L&R has German and Austrian roots).

Maker's page →Source checked

Checked 6 Nov 2026

MakerGermany

HARTMANN Foliodress surgical gowns

PAUL HARTMANN AG

Products: Surgical gowns (Foliodress Gown Protect, Comfort, reinforced versions).

Details

Standard stated: Not stated on page

Note: Country from company name (PAUL HARTMANN AG); page does not name EN 13795.

Maker's page →Source checked

Checked 6 Nov 2026

MakerUSA

Medline surgical gowns and Type IIR masks

Medline

Products: Reinforced surgical gowns (OPS range); Type IIR surgical face mask with shield.

Details

Standard stated: Mask: EN 14683 Type IIR stated; gown page shows 'EN barrier level' without citing the standard

Note: Gown: https://www.medline.eu/uk/ops-essential-fabric-reinforced-surgical-gown

Maker's page →Source checked

Checked 6 Nov 2026

How we compile this page

Laws, guidelines and standards are listed as their publishers state them; makers are listed with the products and standards their own pages state. The lists of makers are not exhaustive and are not an endorsement; NSpine has no commercial relationship with any of them. No medicines or doses are given here: after a sharps injury, follow your occupational health service. We re-check this page every quarter.

Not included or not yet confirmed:

No spine society (NASS, SRS, EUROSPINE, EANS, AO Spine) has published its own guideline on radiation protection; the spine-specific entries are peer-reviewed papers.
The lists of makers are examples, not complete. Each maker's standards and lead-equivalence figures are as stated on its own page.
Some national pages (the German BfS staff pages, Austrian regulations, the RKI post-exposure pages) are still to be added.
The UK post-exposure guidance dates from 2015 and the blood-borne virus guidance from 1998; both are marked as older documents.
3M's medical business is now Solventum, but 3M still lists the face-shield mask; it will be listed once the maker's page states the European standard.
3M surgical mask with face shield: not listed until the maker's page (now Solventum) states the European standard.