About

  • Secretariat: ANSI (United States)
    Committee Manager:
    Ms Jill Zajac
  • Chairperson (until end 2026):
    Mr Changfu Wu
  • ISO Technical Programme Manager [TPM]:
    Ms Jingxian Ma
    ISO Editorial Manager [EM]:
    Ms Sanjali Jain
  • Creation date: 1980

Scope

Standardization of all non-active cardiovascular implants and vascular prostheses, their associated instrumentation, and the instruments and equipment used for blood exchange, renal dialysis, detoxification and taking blood for transfusion or preparation of blood-products.

Quick links

Sustainable Development Goals

This committee contributes with 49 standards to the following Sustainable Development Goals:

3
Good Health and Well-being
9
Industry, Innovation and Infrastructure
41

Published ISO standards *

13

ISO standards under development *

22
Participating members
11
Observing members

* number includes updates

Reference Title Type
ISO/TC 150/SC 2/WG 1   Cardiac valves Working group
ISO/TC 150/SC 2/WG 2   Circulatory support devices Working group
ISO/TC 150/SC 2/WG 3   Vascular prostheses Working group
ISO/TC 150/SC 2/WG 4   Blood gas exchangers Working group
ISO/TC 150/SC 2/WG 5   Renal replacement, detoxification and apheresis Working group
ISO/TC 150/SC 2/WG 6   Vascular device-drug combination products Working group
ISO/TC 150/SC 2/WG 7   Cardiovascular absorbable implants Working group

Liaison Committees to ISO/TC 150/SC 2

The committees below can access the documents of ISO/TC 150/SC 2:

Reference Title ISO/IEC
IEC/SC 62D Particular medical equipment, software, and systems IEC
ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use ISO
ISO/TC 194 Biological and clinical evaluation of medical devices ISO
ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices ISO

 

Liaison Committees from ISO/TC 150/SC 2

ISO/TC 150/SC 2 can access the documents of the committees below:

Reference Title ISO/IEC
ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use ISO
ISO/TC 84 Devices for administration of medicinal products and catheters ISO
ISO/TC 194 Biological and clinical evaluation of medical devices ISO
ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices ISO

 

Organizations in liaison (Category A and B)

Acronym Title Category
ESAO European Society for Artificial Organs A

Organizations in liaison (Category C)

C liaisons participate at the level of a Working Group

Acronym Title Category
SFD Société francophone de dialyse C

ISO/TC 150/SC 2 - Secretariat

ANSI (United States)

Association for the Advancement of Medical Instrumentation
901 N. Glebe Road, Suite 300
Arlington 22203 VA
United States

Tel: +1 703 525 48 90
Fax: +1 703 276 07 93

  2. Taking part
  3. Who develops standards
  4. Technical Committees
  5. ISO/TC 150
  6. SC 2