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B51-14 (R2019) – Boiler, pressure vessel, and pressure piping code

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CSA C22.2 NO. 62841-2-6:22 – Electric motor-operated hand-held tools, transportable tools and lawn and garden machinery — Safety — Part 2-6: Particular requirements for hand-held hammers (Binational standard with UL 62841-2-6)

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CSA C22.2 NO. 62841-2-6:22/A1:24 – Amendment 1:2024 to CSA C22.2 NO. 62841-2-6:22, Electric motor-operated hand-held tools, transportable tools and lawn and garden machinery — Safety — Part 2-6: Particular requirements for hand-held hammers (Binational standard with UL 62841-2-6)

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CAN/CSA-C22.2 NO. 62841-2-5:16 (R2026) – Electric motor-operated hand-held tools, transportable tools and lawn and garden machinery – Safety – Part 2-5: Particular requirements for hand-held circular saws (Bi-national standard with UL 62841-2-5)

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CAN/CSA-C22.2 NO. 62841-2-5:16 (R2026)/A1:26 – Amendment 1:2026 to CAN/CSA-C22.2 NO. 62841-2-5:16, Electric motor-operated hand-held tools, transportable tools and lawn and garden machinery – Safety – Part 2-5: Particular requirements for hand-held circular saws (Bi-national standard with UL 62841-2-5)

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CAN/CSA-C22.2 No. 62841-2-4:15/A1:26 – Amendment 1:2026 (IDT) to CAN/CSA-C22.2 No. 62841-2-4:15, Electric motor-operated hand-held tools, transportable tools and lawn and garden machinery — Safety — Part 2-4: Particular requirements for hand-held sanders and polishers other than disc type (Bi-national standard with UL 62841-2-4)

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CAN/CSA-C22.2 NO. 62841-2-4:15 (R2025) – Electric motor-operated hand-held tools, transportable tools and lawn and garden machinery — Safety — Part 2-4: Particular requirements for hand-held sanders and polishers other than disc type (Bi-national standard with UL 62841-2-4)

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CSA C22.2 NO. 62841-2-3:21/A1:26 – Amendment 1:2026 to CSA C22.2 No. 62841-2-3:21, Electric motor-operated hand-held tools, transportable tools and lawn and garden machinery — Safety — Part 2-3: Particular requirements for handheld grinders, disc-type polishers and disc-type sanders (Binational standard with UL 62841-2-3)

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CSA C22.2 NO. 62841-2-23:25 – Electric motor-operated hand-held tools, transportable tools and lawn and garden machinery — Safety — Part 2-23: Particular requirements for hand-held die grinders and small rotary tools (Binational standard with IEC 62841-2-23)

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CAN/CSA-C22.2 NO. 62841-2-21:18/A1:26 – Amendment 1:2026 to CAN/CSA-C22.2 No. 62841-2-21:18, Electric motor-operated hand-held tools, transportable tools and lawn and garden machinery – Safety – Part 2-21: Particular requirement for hand-held drain cleaners (Adopted amendment 1:2024 to IEC 62841-2-21)

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ISO 11607-3:2026

ISO 11607-3:2026 Packaging for terminally sterilized medical devices — Part 3: Requirements for process development for forming, sealing and assembly

CDN $305.00

This publication was last reviewed and confirmed in 2026.

Packaging for terminally sterilized medical devices — Part 3: Requirements for process development for forming, sealing and assembly

SKU: eda5b4688861 Categories: ,

Description

This document specifies requirements for process development for forming, sealing and assembly of packaging for medical devices to be terminally sterilized, when utilizing heat sealing technologies.

This document recommends minimum heat sealing equipment features to support subsequent validation, process control and monitoring.

This document applies to both preformed sterile barrier systems and sterile barrier systems.

This document utilizes the sterile barrier system specification to develop the process specification using the principles of risk management.

This document is intended to be used prior to process validation.

NOTE            ISO 11607-2 provides requirements for process specification and process validation.

Edition

1

Published Date

2026-09-27

Status

PUBLISHED

Pages

27

Language Detail Icon

English

Format Secure Icon

Secure PDF

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Abstract

This document specifies requirements for process development for forming, sealing and assembly of packaging for medical devices to be terminally sterilized, when utilizing heat sealing technologies.

This document recommends minimum heat sealing equipment features to support subsequent validation, process control and monitoring.

This document applies to both preformed sterile barrier systems and sterile barrier systems.

This document utilizes the sterile barrier system specification to develop the process specification using the principles of risk management.

This document is intended to be used prior to process validation.

NOTE            ISO 11607-2 provides requirements for process specification and process validation.

Previous Editions

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