Back

ISO 17665-1:2006

Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

General information

Withdrawn from 01.03.2024
ICS Groups
11.080.01 Sterilization and disinfection in general
Directives or regulations
None

Standard history

Status
Date
Type
Name
01.03.2024
Main
ISO 17665:2024
17.08.2006
Main
ISO 17665-1:2006
Main
ISO 11134:1994
Main
ISO 13683:1997
ISO 17665-1:2006 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.
Moist heat sterilization processes covered by ISO 17665-1:2006 include but are not limited to:
saturated steam venting systems;saturated steam active air removal systems;air steam mixtures;water spray;water immersion.

Required fields are indicated with *

*
*
*
PDF
82.61 € incl tax
Paper
82.61 € incl tax
Standard monitoring
English (PDF 186 KB)

Related products

Main

ISO 17665:2024

Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
Newest version Valid from 01.03.2024
Main

EVS-EN ISO 11737-2:2020

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
Newest version Valid from 02.06.2020
Main

EVS-EN ISO 11135:2014

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
Newest version Valid from 04.08.2014
Amendment

EVS-EN ISO 11135:2014/A1:2019

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
Newest version Valid from 02.12.2019

Customers who bought this item also bought

Main + corrigendum

EVS-EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Valid from 02.03.2016
Main

EVS-EN ISO 11608-1:2015

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)
Withdrawn from 17.05.2022
Main

ISO 8871-1:2003

Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 1: Extractables in aqueous autoclavates
Newest version Valid from 19.09.2003
Main

ISO 11040-4:2015

Prefilled syringes -- Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
Withdrawn from 03.06.2024

Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English