DD CEN ISO/TS 17665-2:2009

Sterilization of health care products. Moist heat - Guidance on the application of ISO 17665-1

Published:

28 Feb 2009

•

Withdrawn:

1 May 2024

1 Scope

This Technical Specification provides general guidance on the development, validation and routine control of moist heat sterilization processes and is intended to explain the requirements set forth in ISO 17665-1. The guidance given in this Technical Specification is provided to promote good practice related to moist heat sterilization processes and to assist those developing and validating a moist heat sterilization process according to ISO 17665-1.

NOTE 1 The structure of the main body of this ISO Technical Specification (Clauses 1 to 12) corresponds to the structure of ISO 17665-1, so that the guidance given under a particular clause or subclause of this part of ISO 17665 applies to the requirements given in the corresponding clause or subclause of ISO 17665-1. For example, guidance for subclause 5.2 of ISO 17665-1:2006 is given in 5.2. This guidance is provided in addition to the guidance given in ISO 17665-1:2006, Annex A. See also Annexe E.

NOTE 2 Special considerations specific to sterilization processes performed in health care facilities are given in Annex D.

Product Details

Descriptors

Steam

Personnel

Quality assurance

Performance

Installation

Verification

Medical instruments

Sterilizers

Steam sterilizers

Quality control

Medical equipment

Maintenance

Sterilization (hygiene)

Acceptance (approval)

ICS Codes

11.080.01 Sterilization and disinfection in general

Committee

CH/198

International relationships

Identical to:

ISO/TS 17665-2:2009

ISBN

978 0 580 55837 5

Publisher

BSI