Standard Swedish standard · SS-EN ISO 8362-5:2016

Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016)

Status: Valid

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Standard Swedish standard · SS-EN ISO 8362-5:2016

Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016)
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Scope
This part of ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362-1 and ISO 8362-4, which is used in connection with the freeze drying (or lyophilization) of drugs and biological materials.The dimensional requirements are not applicable to barrier-coated closures.Closures specified in this part of ISO 8362 are intended for single use only.NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be strongly affected by the nature and performance of the primary packaging.

Subjects

Transfusion, infusion and injection equipment (11.040.20)


Buy this standard

Standard Swedish standard · SS-EN ISO 8362-5:2016

Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016)
Subscribe on standards - Read more Dölj
Price: 735 SEK
standard ikon pdf

PDF

Price: 735 SEK
standard ikon

Paper

Price: 1 176 SEK
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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-8019627

Edition: 1

Approved: 3/22/2016

No of pages: 24