ISO 11138-1:1994
Sterilization of health care products - Biological indicators - Part 1: General

Standard No.

ISO 11138-1:1994

Release Date

1994

Published By

International Organization for Standardization (ISO)

Status

Withdraw

Replace By

ISO 11138-1:2006

Latest

ISO 11138-1:2017

Scope

Specifies general production, labelling and performance requirements for the manufacture of biological indicators and suspensions intended for use in the validation and monitoring of sterilization cycles. Does not contain requirements for product directly inoculated with test organisms, or recovery procedures for such inoculated product.

ISO 11138-1:1994 Referenced Document

• ISO 11135:1994 Medical devices; validation and routine control of ethylene oxide sterilization
• ISO 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2*， 2006-01-01 Update
• ISO 11137-2 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1*， 2022-06-13 Update
• ISO 11137-3 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control*， 2017-06-01 Update
• ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1*， 2009-12-01 Update
• ISO 11607-2 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1*， 2009-12-01 Update
• ISO 11737-1 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1*， 2021-05-19 Update
• ISO 13485 *， 2018-05-15 Update
• ISO 15223 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied; Amendment 2*， 2004-02-01 Update
• ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices*， 2006-08-01 Update
• ISO 18472 Sterilization of health care products - Biological and chemical indicators - Test equipment*， 2018-07-31 Update
• ISO 8601 Data elements and interchange formats - Information interchange - Representation of dates and times*， 2004-12-01 Update

ISO 11138-1:1994 history

• 2017 ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements
• 2006 ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
• 1994 ISO 11138-1:1994 Sterilization of health care products - Biological indicators - Part 1: General