BS EN ISO 17665

BE EN ISO 17665 provides the general requirements for the sterilisation of healthcare products by moist heat. This includes the periodic testing and validation schedules for steam sterilisers.

Document BS EN 17665
Full Title BS EN ISO 17665 Sterilisation of Healthcare Products – Moist Heat
Applies British, European and International
Sector Healthcare
Covers Steam Sterilisers
Status ALL PARTS CURRENT
 

About BS EN ISO 17665

This document is a two-part British, European and International standard that provides the general requirements for the sterilisation of healthcare products by moist heat.

BS EN 285 and BS EN 13060 both reference this document therefore subsequently so does HTM 2010, CFPP 01-01 and HTM 01-05.

Part 1: (BS EN ISO 17665-1:2006) Requirements for the development, validation and routine control of a sterilization process for medical devices

This document provides requirements for the development, validation and routine control of a sterilization process for medical devices and is used in conjunction with BS EN 285 and BS EN 13060. Tests and methods of test are provided.

Status: CURRENT
Purchase From: www.bsigroup.com
Previous Versions: BS EN 554:1994

Part 2: (ISO/TS 17665-2:2009) Guidance on the application of ISO 17665-1

This document provides guidance on the application of part 1. Periodic test schedules of the tests detailed within part 1 are provided.

Status: CURRENT
Purchase From: www.bsigroup.com
Previous Versions: BS EN 554:1994