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YY 0881-2013 English PDF

YY 0881-2013 English PDF

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YY 0881-2013: Single-use Huber neeldes used for implantable drug-supplying devices

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Scope

This Standard specifies the requirements for single-use Huber needles used for
implantable drug-supplying devices (including infusion needles and hypodermic
needles) to ensure the compatibility of implantable drug-supplying devices and infusion
and injection devices.
This Standard provides guidance on the performance and quality specifications of
materials used for Huber needles.
This Standard does not involve the anti-acupuncture safety requirements for Huber
needles.

Basic Data

Standard ID YY 0881-2013 (YY0881-2013)
Description (Translated English) Single-use Huber neeldes used for implantable drug-supplying devices
Sector / Industry Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard C31
Classification of International Standard 11.040.20
Word Count Estimation 16,177
Quoted Standard GB/T 1962.1; GB/T 1962.2; GB 8368; GB 15811; GB 18457; GB 18671; YY 0286.4-2006; YY/T 0296
Regulation (derived from) State Food and Drug Administration announcement 2013 No. 36; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies: Disposable Needle implantable drug delivery devices (including infusion needle and needle) Requirements, to ensure the implantable drug delivery devices and infusion devices to adapt. The standard material used for the exclusive u


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