Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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031
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Date of Entry 08/06/2013
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FR Recognition Number
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6-275
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Standard | |
ISO 11608-2 Second edition 2012-04-01 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles |
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Scope/AbstractISO 11608-2:2012 specifies requirements and test methods for single-use, double-ended, sterile needles for needle-based injection systems (NISs) that fulfil the specifications of ISO 11608-1. |
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Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Transition Period
FDA recognition of ISO 11608-2 Second edition 2012-04-015 Rec# 6-275 will be superseded by recognition of of ISO 11608-2:2022 Rec# 6-476. FDA will accept declarations of conformity, in support of premarket submissions, to Rec# 6-275 until July 9, 2023. After this transition period, declarations of conformity to Rec# 6-275 will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
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Relevant FDA Guidance and/or Supportive Publications*
Guidance on the Content of Premarket Notification {510(k)} Submissions for Piston Syringes. Issued April 1993
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contacts
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Standards Development Organization
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FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital |
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*These are provided as examples and others may be applicable. |