SIS-EN-ISO-11607-1 › Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)

SIS-EN-ISO-11607-1 - 2018 EDITION - SUPERSEDED -- See the following: SS-EN-ISO-11607-1
Show Complete Document History

Document Center Inc. is an authorized dealer of SIS standards.
The following bibliographic material is provided to assist you with your purchasing decision:


ISO 11607-1:2006 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized. ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations. ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture.

To find similar documents by classification:

11.080.30 (Sterilized packaging)

55.040 (Packaging materials and accessories Including wrappers, paper, films, foils, cords, sealing devices, cushioning, etc. Adhesive tapes for general purposes, see 83.180)

85.060 (Paper and board)


Active implantable medical devices. Medical devices. Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

 

Customers who bought this document also bought:

ASTM-D4169
Standard Practice for Performance Testing of Shipping Containers and Systems

ASTM-F88
Standard Test Method for Seal Strength of Flexible Barrier Materials

ASTM-F1980
Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices

ORDER

Want this as a site license?



Designation Name

SS-EN ISO 11607-1:2018

Revision Level

2018 EDITION

Status

Superseded

Publication Date

Jan. 1, 2018

Language(s)

English

Page Count

48

International Equivalent

EN ISO 11607-1:2017(IDT); ISO 11607-1:2006(IDT)