NF EN ISO 11607-1/A11

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1 : exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage - Amendement A11

Packaging for terminally sterilized medical devices - Part 1 : requirements for materials, sterile barrier systems and packaging systems - Amendment A11

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1 : Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme - Änderung 11

Information:

Summary:

Le présent amendement ajoute les Annexes ZA, ZB et ZC à la norme homologuée NF EN ISO 11607-1, de janvier 2020.

Date:

2022-06-15 / ACTIVE

Idiomas Disponibles:

Inglés, Francés

ICS:

11.080.30 - Sterilized packaging

55.040 - Packaging materials and accessories cushioning, etc.

Keywords:

medical devices; sterilization; packing; materials; protection; sterility; ; design; characteristics; permeability; migrations; microorganisms; labelling; compatibility; tests; stability tests; quality; sampling; ; definitions

Relationship with other AENOR standards:

Modifica a: NF EN ISO 11607-1:202001 (S98-052-1)

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