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CH/194 - Biological evaluation of medical devices

Committee standards activity

In Progress (31)
Reference Standards description
Status ?

The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.

PD ISO/TS 29741 Biological evaluation of medical devices -- Development of tolerable intake values for Di(2-ethylhexyl)phthalate (DEHP)

Categories: Unclassified documents

Drafting begins : 2018-06-01
Drafting
PD ISO/TS 25364-3 Analytical chemistry matters associated with ISO 10993-18 — Part 3: Instrumental and human requirements for performing Non-Targeted Analysis for organic medical device extractables and leachables via Non-Target Analysis (NTA)

Categories: Unclassified documents

Drafting begins : 2025-05-13
Drafting
PD ISO/TS 25364-2 Analytical chemistry matters associated with ISO 10993-18 — Part 2: Quantification of medical device extractables and leachables using Non-Targeted Analysis (NTA)

Categories: Unclassified documents

Drafting begins : 2025-05-22
Drafting
PD ISO/TS 25364-1 Analytical chemistry matters associated with 10993-18 — Part 1: Identification of organic medical device extractables and leachables via Non-Target Analysis (NTA)

Categories: Unclassified documents

Drafting begins : 2025-05-13
Drafting
PD ISO/TR 37137-2 Biological evaluation of absorbable medical devices. Part 2: Standard guide for absorbable metals

Categories: Implants for surgery, prosthetics and orthotics

Approval begins :
Approval
PD ISO/TR 21582 Pyrogenicity — Principles and methods for pyrogen testing of medical devices

Categories: Unclassified documents

Proposal begins :
Proposal
ISO/NP TS 25364-4 - Analytical chemistry matters associated with ISO 10993-18 — Part 4: Critical aspects of extract viability in extractables and leachables testing using non-targeted analysis (NTA)

Categories: Information management | Standardization. General rules

Proposal begins : 2025-04-03
Proposal
ISO/NP TS 25364 Discovery, Identification and Quantification of Medical Device Extractables and Leachables via Non-Target Analysis (NTA) — Analytical Chemistry Matters Associated with ISO 10993-18

Categories: Information management | Standardization. General rules

Proposal begins : 2024-07-14
Proposal
ISO/NP 25 Medical devices utilizing bioengineered biological substances — Application of risk management

Categories: Information management | Standardization. General rules

Proposal begins : 2025-01-13
Proposal
Draft Decision CEN/TC 206 003/2023 Medical devices utilizing human tissues and their derivatives -- Application of risk management

Categories: Standardization. General rules | Quality | Healthcare | Medical equipment | Sterilization and disinfection | Medical devices. Biological evaluation

Proposal begins : 2023-08-04
Proposal
Published (41)
Reference Standards description
Status ?

The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.

PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices. General requirements

Categories: Implants for surgery, prosthetics and orthotics

Published standard begins : 2021-03-15
Published standard
PD ISO/TS 21726:2019 Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents

Categories: Medical devices. Biological evaluation

Published standard begins : 2019-02-05
Published standard
PD ISO/TS 11796:2023 Biological evaluation of medical devices. Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices

Categories: Medical devices. Biological evaluation

Published standard begins : 2023-08-02
Published standard
PD ISO/TS 10993-19:2020 Biological evaluation of medical devices. Physico-chemical, morphological and topographical characterization of materials

Categories: Medical devices. Biological evaluation

Published standard begins : 2020-03-16
Published standard
PD ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants

Categories: Implants for surgery, prosthetics and orthotics

Published standard begins : 2014-06-06
Published standard
PD ISO/TR 22442-4:2010 Medical devices utilizing animal tissues and their derivatives. Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes

Categories: Medical devices. Biological evaluation

Published standard begins : 2011-02-16
Published standard
PD ISO/TR 21582:2021 Pyrogenicity. Principles and methods for pyrogen testing of medical devices

Categories: Medical devices. Biological evaluation

Published standard begins : 2021-07-28
Published standard
PD ISO/TR 15499:2016 Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process

Categories: Medical devices. Biological evaluation

Published standard begins : 2017-01-04
Published standard
PD ISO/TR 10993-55:2023 Biological evaluation of medical devices. Interlaboratory study on cytotoxicity

Categories: Medical devices. Biological evaluation

Published standard begins : 2023-02-20
Published standard
PD ISO/TR 10993-33:2015 Biological evaluation of medical devices. Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3

Categories: Medical devices. Biological evaluation

Published standard begins : 2015-03-24
Published standard
Withdrawn (54)
Reference Standards description
Status ?

The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.

PD ISO/TR 15499:2012 Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process

Categories: Medical devices. Biological evaluation

Withdrawn begins : 2017-01-04
Withdrawn
DD ISO/TS 10993-19:2006 Biological evaluation of medical devices. Physico-chemical, morphological and topographical characterization of materials

Categories: Medical devices. Biological evaluation

Withdrawn begins : 2020-03-16
Withdrawn
BS EN ISO 9363-1:1999 Optics and optical instruments. Contact lenses. Determination of cytotoxicity of contact lens material. Agar overlay test and growth inhibition test

Categories: Medical equipment. Ophthalmic

Withdrawn begins : 2023-09-22
Withdrawn
BS EN ISO 22442-2:2007 Medical devices utilizing animal tissues and their derivatives. Controls on sourcing, collection and handling

Categories: Medical devices. Biological evaluation

Withdrawn begins : 2015-12-08
Withdrawn
BS EN ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives. Application of risk management

Categories: Medical devices. Biological evaluation

Withdrawn begins : 2015-11-27
Withdrawn
BS EN ISO 14155:2020 Clinical investigation of medical devices for human subjects. Good clinical practice

Categories: Medical devices. Biological evaluation

Withdrawn begins : 2020-08-19
Withdrawn
BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice

Categories: Medical devices. Biological evaluation

Withdrawn begins : 2011-09-16
Withdrawn
BS EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects. Clinical investigation plans

Categories: Medical devices. Biological evaluation

Withdrawn begins : 2011-02-22
Withdrawn
BS EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects. Clinical investigation plans

Categories: Medical equipment. General | Medical devices. Biological evaluation

Withdrawn begins : 2010-01-15
Withdrawn
BS EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects. General requirements

Categories: Medical devices. Biological evaluation

Withdrawn begins : 2011-02-22
Withdrawn