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NEN-EN-ISO 11139/A1

Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards - Amendment 1: Amended and additional terms and definitions

active, Most Current
Organization: NEN
Publication Date: 1 January 2024
Status: active
Page Count: 26
ICS Code (Health care technology (Vocabularies)): 01.040.11
ICS Code (Sterilization and disinfection in general): 11.080.01

Document History

NEN-EN-ISO 11139/A1
January 1, 2024
Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards - Amendment 1: Amended and additional terms and definitions
A description is not available for this item.
NEN-EN-ISO 11139
September 1, 2018
Sterilization of health care products - Vocabulary - Terms used in sterilization and related equipment and process standards
This document defines terms in the field of the sterilization of health care products including related equipment and processes.

References

This document references:
ASTM E2587 - Standard Practice for Use of Control Charts in Statistical Process Control
Published by ASTM on April 1, 2016
This practice provides guidance for the use of control charts in statistical process control programs, which improve process quality through reducing variation by identifying and eliminating the...
This document references:
11737-3 - Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing
Published by ISO on June 1, 2023
Inclusions This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in health care products, components or raw materials using bacterial endotoxins...
This document references:
ISO 20417 - Medical devices — Information to be supplied by the manufacturer
Published by ISO on April 1, 2021
NOTE 1 There is guidance or rationale for this Clause contained in Clause A.2. This document specifies the requirements for information supplied by the manufacturer for a medical device or by the...
This document references:
ISO TS 22421 - Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
Published by ISO on January 1, 2021
This document specifies the common requirements for sterilizers used for terminal sterilization of medical devices in health care facilities. This document covers sterilizers that operate with a...
This document references:
ISO TS 22456 - Sterilization of healthcare products — Microbiological methods — Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
Published by ISO on March 1, 2021
Inclusions This document provides guidance for bioburden testing and tests of sterility for biologics and tissue-based products, where this testing is in relation to product sterilization. NOTE This...
This document references:
ISO/ASTM 52303 - Guide for absorbed-dose mapping in radiation processing facilities
Published by ISO on July 15, 2015
This document provides guidance in determining absorbed-dose distributions (mapping) in products, materials or substances irradiated in gamma, X-ray (bremsstrahlung) and electron beam facilities....
This document references:
ISO/IEC GUIDE 63 - Guide to the development and inclusion of aspects of safety in International Standards for medical devices
Published by ISO on August 1, 2019
This document provides requirements and recommendations to writers of medical device standards on the inclusion of aspects related to safety in International Standards, based on well-established risk...
This document references:
ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Published by ISO on August 1, 2018
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the...
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