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YY 0678-2008

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YY 0678-2008 英文版 295 购买 现货,9秒内自动发货PDF,有增值税发票。 医用冷冻外科治疗设备性能和安全 有效

   
标准详细信息 YY 0678-2008; YY0678-2008
中文名称: 医用冷冻外科治疗设备性能和安全
英文名称: Standard performance and safety specification for cryosurgical medical instruments
行业: 医药行业标准
中标分类: C37
国际标准分类: 11.040.60
字数估计: 8,000
发布日期: 2008-10-17
实施日期: 2010-06-01
引用标准: GB/T 1226-2001; GB 9706.1; GB 15382-1994; 气瓶安全监察规定 国家质量监督检验检疫总局令第46号令
采用标准: ASTM F882-1984(2002), MOD
起草单位: 国家食品药品监督管理局杭州医疗器械质量监督检验中心
归口单位: 国家食品药品监督管理局杭州医疗器械质量监督检验中心
标准依据: 国食药监械[2008]605号
提出机构: 国家食品药品监督管理局杭州医疗器械质量监督检验中心
发布机构: 国家食品药品监督管理局
范围: 本标准规定了医用冷冻外科治疗设备在冷冻系统性能和复现性、公布、标记、文件和安全方面所应遵循的基本要求。本标准所指医用冷冻外科治疗设备采用相变汽化潜热或焦耳-汤姆逊效应原理, 在冷冻探杆内或直接在靶组织产生低温, 用于产生冷冻坏死、炎性反应或冷冻粘连。医用冷冻外科设备使用时是由可显示冷冻探头或冷冻区域温度的附件来对治疗过程进行监测的, 本标准的要求适用于这些附件。

YY 0678-2008
Standard performance and safety specification for cryosurgical medical instruments
ICS 11.040.60
C37
中华人民共和国医药行业标准
YY0678-2008
医用冷冻外科治疗设备性能和安全
(ASTMF882-84[Reapproved2002],MOD)
2008-10-17发布
2010-06-01实施
国家食品药品监督管理局 发 布
前言
本标准修改采用ASTMF882-84(Reapproved2002)《医用冷冻设备性能和安全》。
本标准与ASTMF882-84(Reapproved2002)的差异如下:删除了有关连续漏电流、与易燃性麻
醉混合气点燃危险的防护和确定温度监测器(冷冻探头和组织)正确度等内容。
本标准由国家食品药品监督管理局杭州医疗器械质量监督检验中心提出并归口。
本标准起草单位:国家食品药品监督管理局杭州医疗器械质量监督检验中心。
本标准主要起草人:孙瑜、杜、叶岳顺、方乐、韩坚城、马莉。
YY0678-2008
医用冷冻外科治疗设备性能和安全
1 范围
本标准规定了医用冷冻外科治疗设备在冷冻系统性能和复现性、公布、标记、文件和安全方面所应
遵循的基本要求。
本标准所指医用冷冻外科治疗设备采用相变汽化潜热或焦耳-汤姆逊效应原理,在冷冻探杆内或直
接在靶组织产生低温,用于产生冷冻坏死、炎性反应或冷冻粘连。
医用冷冻外科设备使用时是由可显示冷冻探头或冷冻区域温度的附件来对治疗过程进行监测的,
本标准的要求适用于这些附件。
2 规范性引用文件
下列文件中的条款通过本标准的引用而成为本标准的条款。凡是注日期的引用文件,其随后所有
的修改单(不包括勘误的内容)或修订版均不适用于本标准,然而,鼓励根据本标准达成协议的各方研究
是否可使用这些文件的最新版本。凡是不注日期的引用文件,其最新版本适用于本标准。
GB/T 1226-2001 一般压力表
GB 9706.1 医用电气设备 第1部分:安全通用要求(GB 9706.1-2007,IEC 60601-1:1988,IDT)
GB 15382-1994 气瓶阀通用技术条件
气瓶安全监察规定 国家质量监督检验检疫总局令 第46号令
3 术语和定义
下列术语和定义适用于本标准。
3.1
中空,末端封闭,通常其形状符合特定解剖学的部位,低温工质通过末端的外表面冷冻靶组织。
3.2
专门设计将低温工质直接输送到靶组织的装置。
3.3
向冷冻探头或开口末端传递低温工质的装置。当用于冷冻探头时,冷冻探杆也可引导低温工质离
开靶组织。
3.4
为使用低温工质而设计的所有系统组件但不包括低温工质及非制造商提供的容器。
3.5
专门设计用来储存高压气体或液体的容器。
3.6
专门设计的连接设备,使压缩气储罐介质按需安全地释放。
YY0678-2008

YY 0678-2008
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.60
C 37
Standard Performance and Safety Specification
for Cryosurgical Medical Instruments
医用冷冻外科治疗设备性能和安全
(ASTM F 882-84[Reapproved 2002], MOD)
ISSUED ON. OCTOBER 17, 2008
IMPLEMENTED ON. JUNE 1, 2010
Issued by. China Food and Drug Administration
Table of Contents
1 Scope ... 4 
2 Normative References ... 4 
3 Terms and Definitions ... 5 
4 Cryosystem Performance and Reproducility Requirements ... 7 
5 Disclosure, Labeling, and Documentation Requirements ... 10 
6 Cryosystem Safety Requirements ... 14 
Foreword
This Standard modifies and adopts ASTM F 882-84 (Reapproved 2002) “Performance
and Safety Cryosurgical Medical Instruments”.
The differences between this Standard and ASTM F 882-84 (Reapproved 2002) are
as follows. Delete the contents such as continuous leakage current, protection against
combustibility anesthesia gas mixture ignition danger, and determining temperature
monitor (cryotip and tissue) accurateness.
This Standard was proposed by and shall be under the jurisdiction of Hangzhou
Medical Appliance Quality Supervision Testing Center of China State Food and Drug
Administration.
Drafting organization of this Standard. Hangzhou Medical Appliance Quality
Supervision Testing Center of China State Food and Drug Administration
Chief drafting staffs of this Standard. Sun Yu, Du Long, Ye Yue Shun, Fang Le, Han
Jiancheng, and Ma li.
Standard Performance and Safety
Specification for Cryosurgical Medical
Instruments
1 Scope
This Standard specifies the basic requirements that cryosurgical medical instrument in
refrigeration system shall meet in the performance, reproducibility, publication,
labelling, documentation, and safety aspects.
The cryosurgical medical instrument referred in this Standard adopts the principle of
Latent Heat of Vaporization or the Joule-Thompson Effect, produces low temperature
in cryotip rod or directly to the target tissue, so as to produce cryonecrosis,
inflammatory response or cryoadhesion.
If, during the application, cryosurgical medical instrument utilizes displayable cryotip
or accessories at cryogen area temperature to monitor the treatment process, the
requirements of this Standard are applicable to these accessories.
2 Normative References
The following normative documents contain provisions which, through reference in
this text, constitute the provisions of this Standard. For dated references, subsequent
amendments (excluding corrigendum) or revisions of these publications do not apply.
However, all parties who enter into an agreement according to this Standard are
encouraged to study whether the latest editions of these documents are applicable.
For undated references, the latest editions of the normative documents referred to
applies.
GB/T 1226-2001 General Pressure Gauge
GB 9706.1 Medical Electrical Equipment - Part 1. General Requirements for
Safety (GB 9706.1-2007, IEC 60601-1.1988, IDT)
GB 15382-1994 General Technique Specifications for Cylinder Valves
Safety Inspection Regulations for Gas Cylinders, AQSIQ Decree No. 46
3 Terms and Definitions
For the purpose of this Standard, the following terms and definitions apply.
3.1 closed cryotip
a hollow, closed end usually shaped to fit a particular anatomical site where the
cryogen cools the external surface which is applied to the target tissue.
3.2 open cryotip
a device specifically designed to apply the cryogen directly to the target tissue.
3.3 cryoprobe
the instrument used to deliver the cryogen to the cryotip or open tip. For a cryotip, a
3.4 cryosystem
all parts of a system excluding the cryogen and its container, unless supplied by the
manufacturer, that is designed to apply or use a cryogen.
3.5 compressed gas cylinder
a container that is specifically designed to store a gas or liquid under elevated
pressure conditions.
3.6 compressed gas cylinder connector
a device specifically designed to attach to a cylinder for proper and safe removal of its
contents.
connected device specially designed to make the cryogen in the container be
released as required.
3.8 cryogen
a substance used to obtain reduced temperatures.
Note. Cryogens are usually classed by their boiling points. The most common cryogens
and their respective boiling points are as follows.
Cryogen Boiling Point at S.T.P.,°C
Freon 22 −49.8
Carbon Dioxide (CO2) −78.6
30°C±2°C by a constant temperature bath. The water in the beaker shall
not be circulated artificially during the actual test.
- Fast thermal thermocouple sensor.
- Temperature indicator or chart recorder.
- Other components, to make the cryosystem functional in accordance with
the manufacturer’s operational instructions.
b) Sampling.
- For limited production or a unique cryosystem, perform and record a series
of three freeze modes.
systems.
c) Procedure.
- Attach the thermocouple sensor to the therapeutic surface of the cryotip as
determined by the manufacturer.
- Immerse the closed cryotip into the simulated tissue model in a way which
stimulates the intended application as determined by the manufacturer.
- Follow all parameters as described in the manufacturer’s operational
instructions to make cryosystem functional.
- Allow the cryotip to defrost between cycles.
- A pre-cycle for the cryosystems to normalize operating conditions is
permitted.
- Calculate the reference temperature and limits of deviation from the
recorded data.
d) Conformance.
Conformance with the requirements shall be checked by comparison of the
deviation between the closed cryotip reference temperature and Table 1.
4.3 Tractive Force of Closed Cryotip
All the Cryosystem specially designed for cryoadhesion shall be able to lift weight of
manufacturer may label his product as conforming to this Standard only if the product
fulfills the requirements of this specification.
5.2 Disclosure
A manufacturer shall disclose each specification listed, where applicable.
5.2.1 A manufacturer of a cryosystem shall provide a warning statement to inform
the user where contact with the cryosystem may cause user/patient harm. This
statement shall appear in the instrument’s instruction manual and, if possible, on
sections of the instrument that become 0°C or colder.
5.2.2 A cryosystem designed to spray a cryogen onto a target tissue must have a
the patient due to excess or residual cryogen droplets or mist.
5.2.3 A disclosure statement shall be required that states the normal operating
pressure at +20°C, the boiling point, and the type of cryogen for which the instrument
is designed.
5.2.4 A disclosure statement that states exactly what items of the cryosystem and its
accessories can be sterilized and the recommended sterilization procedures shall be
included with each cryosystem.
5.2.5 A disclosure statement shall be included with each pre-sterilized cryosystem.
a) Sterile;
c) Notes of caution concerning means of shipping, storage and use of the
instrument.
5.2.6 All ac powered cryosystems and accessories shall be prominently labeled
“Danger-Explosion Hazard. Do Not Use in Presence of Flammable Anesthetics”.
5.2.7 The following information shall be included in the disclosure statement for
tissue temperature monitors.
a) Type of cryometer (analog, digital, recorder),
b) Temperature range. minimum to maximum,
c) Type of thermocouple (for example, Type “T”),
e) Power requirements.
c) Set up;
d) Use;
e) Dismantle;
f) Calibrations;
g) Intended Applications.
5.4.2.1 Specifications – Cryosystem and Cryogen.
a) Size;
b) Weight;
d) Minimum and Maximum Operation Pressure;
e) Power Requirements;
f) Temperature Control Description;
g) Cryosystem and Cryoprobe Performance Check
b) Defrost Features;
i) Temperature Sensor;
j) Serviceable Parts;
k) Manufacturer’s Recommended Cryogen Containers;
l) Thermal Insulation;
5.4.2.2 Recommended Withdrawal Devices.
a) Type(s) of Cryogen Employed;
b) Size;
c) Weight;
d) Capacity;
e) Static Hold Time. Container Only;
f) Static Hold Time. Container and Withdrawal Device;
g) Optimum and Maximum Operating Pressure;
h) Rating on Pressure Limiting Device;
j) Serviceable Parts.
5.4.3 Servicing Instructions.
a) Trouble-Shooting Chart;
b) Cryogen Flow Chart;
c) Electrical Schematics;
d) User Serviceable Parts List;
e) Preventive Maintenance Recommendations;
f) Warranty Information.
5.4.4 Electrical and Cryogen Safety Instructions.
b) Patient Related.
5.4.5 Available Accessories.
6 Cryosystem Safety Requirements
6.1 General
These cryosystem safety requirements are intended to protect the user and patient
from harm during the use and storage of the cryosystem.
6.2 Mechanical Integrity
6.2.1 ...
   
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