EFHSS Questions and Answers - Question Q00141

Dear All,

Hi, I am from India. And I wish to know that for the sterilization packaging reels (flat rolls) what are the recommended British Standards one must look for from the supplier. Is it BS 6871? also what is BS 6257 - is it pertaining to sterilization packaging materials? We are all confused here in India about the British standards that one must look for from the supplier. As here in India, we do not have any standards, hence we request you to kindly let us know what are the essential standards and also what is the signifance of EN 868 standards.

Regards,
A. Gupta.

Dear Anchal,

EN 868-1 Packaging materials and systems for medical devices which are to be sterilized -
PART 1: General requirements and test methods states clearly on page 3:
"This European standard was approved by CEN on 1997-01-27. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alternation".

The foreword of EN 868 repeats:
"This European standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by August 1997, and conflicting national standards shall be withdrawn at the latest by August 1997.
According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria,.....and the United Kingdom.
This standard is the first of a series of European standards concerned with packaging material and systems for medical devices which are to be sterilized.
EN 868-5 is about: Heat sealable pouches and reel material manufactured from paper and plastic - Requirements and test methods."

I think hereby the significance and importance of the European Norms should become clear.
Kind regards,
Wim Renders