If you have difficulty in submitting comments on draft standards you can use a commenting template and email it to admin.start@bsigroup.com. The commenting template can be found here.

We use cookies to give you the best experience and to help improve our website

Find out what cookies we use and how to disable them

Healthcare

Healthcare Sub-categories (11)

  1. Medical sciences and health care facilities. General
  2. Medical equipment
  3. Dentistry
  4. Sterilization and disinfection
  5. Laboratory medicine
  6. Pharmaceutics
  7. Hospital equipment
  8. First aid
  9. Aids. Disabled persons
  10. Birth control. Mechanical contraceptives
  11. Veterinary medicine

Latest standards activities

Proposals
Drafts

BS EN ISO 11117:2019/Amd 1

Gas cylinders — Valve protection caps and guards — Design, construction and tests - Amendment 1: Gas cylinders — Valve protection caps and guards — Design, construction and tests — Amendment 1

Feedback closing date:

10/03/2026

View 0

BS EN ISO 18730

Anaesthetic and respiratory equipment — Waste volatile anaesthetic agent capture systems

Feedback closing date:

08/03/2026

View 0

BS EN IEC 60601-1/FRAG9

BS EN 60601-1/FRAG9 ED4 Medical electrical equipment. Part 1: General requirements for basic safety and essential performance - Optical radiation hazards (Fragment 9)

Feedback closing date:

11/02/2026

View 0

BS ISO 21064

Prosthetics and orthotics — Foot orthotics (pedorthics) — Uses, functions classification and description

Feedback closing date:

09/02/2026

View 0

BS EN ISO 18969

Clinical evaluation of medical devices

Feedback closing date:

07/02/2026

View 13

BS EN ISO 80601-2-56

Medical electrical equipment —. Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

Feedback closing date:

09/02/2026

View 0

BS 8599-1:2019+A1:2026

Workplace first aid kits - Specification for the contents of workplace first aid kits

Feedback closing date:

11/02/2026

View 1

BS EN ISO 10993-16

Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables

Feedback closing date:

31/01/2026

View 0
Feedback period expiring

BS EN ISO 8537

Sterile single-use syringes, with or without needle, for insulin

Feedback closing date:

24/01/2026

View

BS EN ISO 7886-1

Sterile hypodermic syringes for single use — Part 1: Syringes for manual use

Feedback closing date:

24/01/2026

View
Published

BS EN 18000-2:2026

Animal health diagnostic analyses. Control of in vitro diagnostic reagents. Reagents for immunological techniques

View

BS EN 18000-1:2026

Animal health diagnostic analyses. Control of in vitro diagnostic reagents. Application file for the initial and the batch-to-batch control

View

BS EN ISO 10993-17:2023+A1:2025

Biological evaluation of medical devices. Toxicological risk assessment of medical device constituents

View

BS EN ISO 10993-1:2025

Biological evaluation of medical devices. Requirements and general principles for the evaluation of biological safety within a risk management process

View

BS ISO 22544:2025

Laboratory design — Vocabulary

View

BS EN ISO 1135-4:2025

Transfusion equipment for medical use. Transfusion sets for single use, gravity feed

View

BS EN ISO 1135-5:2025

Transfusion equipment for medical use. Transfusion sets for single use with pressure infusion apparatus

View

BS EN ISO 17510:2025

Medical devices — Sleep apnoea breathing therapy — Masks and application accessories

View