We need your consent to use the individual data so that you can see information about your interests, among other things. Click "OK" to give your consent.
Standard Guide for Writing a Specification for Sterilizable Peel Pouches (Includes all amendments And changes 10/14/2015).
Automatically translated name:
Standard Guide for Writing a Specification for Sterilizable Peel Pouches
STANDARD published on 1.10.2010
Designation standards: ASTM F2559/F2559M-06(2010)e1
Note: WITHDRAWN
Publication date standards: 1.10.2010
SKU: NS-54126
The number of pages: 6
Approximate weight : 18 g (0.04 lbs)
Country: American technical standard
Category: Technical standards ASTM
Keywords:
chevron pouch, corner peel pouch, header bag, peel pouch, specification, Sterile medical device packages, Flexible barrier materials, ICS Number Code 11.120.99 (Other standards related to pharmaceutics)
Significance and Use | ||||||||||||||||||||||
Medical device peel pouches are universally used by the industry and produced by a myriad of suppliers. They may be constructed of many different materials including films, foils, paper, nonwovens such as Tyvek, and combinations thereof. However, even with the diversity of materials, there are still basic requirements that all pouches should exhibit. Above all, the pouches must contain and protect the device while maintaining sterility during all physical handling. Pouch requirements may be divided into two categories, initial pouch and material qualification, and routine production and receipt requirements to ensure the purchaser receives exactly what is ordered. While all requirements should be included in the written specification, initial qualification tests may only be needed prior to the first order. Routine production and receipt requirements should be adhered to on every order. Initial qualification requirements are indicated within each clause, where applicable. This guide provides an understanding of the requirements needed for the manufacture, purchase, and acceptance of a preformed peelable pouch. Appropriate test methods for compliance are also cited. Note 1—All test methods for a particular requirement may not be cited due to specific or unique circumstances. For additional guidance on applicable methods, refer to Guide F2097. The specification and its requirements should be mutually agreed to by the supplier and purchaser of pouches. This helps ensure that pouches will comply to specified requirements. |
||||||||||||||||||||||
1. Scope | ||||||||||||||||||||||
1.1 This guide defines the requirements and considerations for flexible peel pouches with one open, unsealed end that are intended to be sterilized containing medical devices. These are also known as preformed sterile barrier systems. 1.2 Pouch styles are categorized as chevron, header, and corner peel. These pouches are typically manufactured by heat sealing, or in some cases, by cohesive cold sealing. The sealing bond is intended to be peeled open to aseptically dispense the contents. 1.3 Pouch materials may be either porous, nonporous, or any combination of the two. 1.4 This guide addresses some critical printing requirements on the pouch. 1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. |
||||||||||||||||||||||
2. Referenced Documents | ||||||||||||||||||||||
|
Do you want to be sure about the validity of used regulations?
We offer you a solution so that you could use valid and updated legislative regulations.
Would you like to get more information? Look at this page.
Latest update: 2024-09-01 (Number of items: 2 345 425)
© Copyright 2024 NORMSERVIS s.r.o.