YY/T 0907-2023 Active Industry standards-Medicine

YY/T 0907-2023 Needle-free injectors for medical use—Requirements and test methods

YY/T 0907-2023 Needle-free injectors for medical use—Requirements and test methods

Publish Date: 2023-06-20 Implement Date: 2024-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0907-2023
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Generally, it refers to microsurgical instruments
ICS Name: Blood transfusion, infusion, and injection equipment
Publish Date: 2023-06-20
Implement Date: 2024-07-01
Publisher: 国家药品监督管理局
Technical Committee: 全国医用注射器(针)标准化技术委员会(SAC/TC 95)
Pages: 33 pages

Scope

本文件规定了在临床和相关医疗环境下使用的或个人使用的一次或多次使用的医用无针注射器(以下简称“无针注射器”)的要求和试验方法。
本文件适用于在临床和相关医疗环境下使用的或个人使用的一次或多次使用的无针注射器。
注: 无针注射器的药剂腔通常是丢弃式的,在一次使用或有限次数使用后将其更换。有时它与注射机械装置是分离的,并且通常称为“药筒”“安瓿”“注射器”“胶囊”或者“圆盘”。反之,药剂腔也可以是永久的内腔,其使用性能在有效期内能够保持有效。

Development Information

Drafting Units:

北京快舒尔医疗技术有限公司、上海市医疗器械检验研究院、江西三鑫医疗科技股份有限公司

Drafting Persons:

祁欣、陆离原、花松鹤、王丹、王甘英

Word Count: 58 Thousand words Pages: 33 pages

Replace the following standards

Referenced Standards

GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices GB/T 16886.13-2017 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices GB/T 16886.14-2003 Biological evaluation of medical devices—Part 14:Identification and quantification of degradation products from ceramics GB/T 16886.15-2003 Biological eveluation of medical devices—Part 15:Identification and quantification of degradation products from metals and alloys GB/T 16886.15-2022 Biological evaluation of medical devices—Part 15:Identification and quantification of degradation products from metals and alloys GB/T 16886.16-2003 Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables GB/T 16886.16-2013 Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables GB/T 16886.16-2021 Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables GB/T 16886.17-2005 Biological evaluation of medical devices—Part 17:Establishment of allowable limits for leachable substances GB/T 16886.17-2025 Biological evaluation of medical devices—Part 17:Toxicological risk assessment of medical device constituents GB/T 16886.18-2011 Biological evaluation of medical devices—Part 18:Chemical characterization of materials GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18:Chemical characterization of medical device materials within a risk management process GB/T 16886.19-2011 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials GB/T 16886.20-2015 Biological evaluation of medical devices—Part 20:Principles and methods for immunotoxicology testing of medical devices GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials GB/T 16886.23-2023 Biological evaluation of medical devices—Part 23:Tests for irritation GB/T 17248.2-1999 Acoustics—Noise emitted by machinery and equipment—Measurement of emission sound pressure levels at a work station and at other specified positions—Engineering method in an essentially free field over a reflecting plane GB/T 17248.2-2018 Acoustics—Noise emitted by machinery and equipment—Determination of emission sound pressure levels at a work station and at other specified positions in an essentially free field over a reflecting plane with negligible environmental corrections GB/T 17248.3-1999 Acoustics—Noise emitted by machinery and equipment—Measurement of emission sound pressure levels at a work station and at other specified positions—Survey method in situ GB/T 17248.3-2018 Acoustics—Noise emitted by machinery and equipment—Determination of emission sound pressure levels at a work station and at other specified positions applying approximate environmental corrections GB/T 17248.5-1999 Acoustics—Noise emitted by machinery and equipment—Measurement of emission sound pressure levels at a work station and at other specified positions—Method requiring environmental corrections GB/T 17248.5-2018 Acoustics—Noise emitted by machinery and equipment—Determination of emission sound pressure levels at a work station and at other specified positions applying accurate environmental corrections GB/T 17626.2-2018 Electromagnetic compatibility—Testing and measurement techniques—Electrostatic discharge immunity test GB/T 17626.3-2016 Electromagnetic compatibility—Testing and measurement techniques—Radiated,radio-frequency,electromagnetic field immunity test GB/T 18779.1-2022 Geometrical product specifications (GPS)—Inspection by measurement of workpieces and measuring equipment—Part 1:Decision rules for verifying conformity or nonconformity with specifications ISO 16269-6:2014 测量不确定度评定和表示指南(GUM)

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ISO 21649:2006

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