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GB/T 43952-2024: Medical supply units
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Medical supply units
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GB/T 43952-2024
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Basic data | Standard ID | GB/T 43952-2024 (GB/T43952-2024) | | Description (Translated English) | Medical supply units | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C46 | | Classification of International Standard | 11.040.10 | | Word Count Estimation | 34,369 | | Date of Issue | 2024-06-29 | | Date of Implementation | 2025-07-01 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 43952-2024: Medical supply units---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.040.10
CCSC46
National Standards of People's Republic of China
Medical supply equipment
(ISO 11197.2019,MOD)
Released on 2024-06-29
2025-07-01 Implementation
State Administration for Market Regulation
The National Standardization Administration issued
Table of Contents
Preface III
Introduction V
201.1 Scope, purpose and related standards 1
201.2 Normative references 2
201.3 Terms and Definitions 3
201.4 General requirements 3
201.5 General requirements for testing of ME EQUIPMENT 4
201.6 Classification of me equipment and me systems 4
201.7 ME EQUIPMENT IDENTIFICATION, MARKING AND DOCUMENTATION 4
201.8 Protection of ME EQUIPMENT against hazards of electric shock 7
201.9 Protection of me equipment and me systems against mechanical hazards 13
201.10 Protection against unwanted or excessive radiation hazards (sources) 15
201.11 Protection against overtemperature and other hazards (sources) 15
201.12 Accuracy of controls and instruments and protection against hazardous outputs 16
201.13 Hazardous situations and fault conditions 16
201.14 Programmable electrical medical systems (PEMS) 16
201.15 Construction of ME EQUIPMENT 16
201.16 ME System 19
201.17 Electromagnetic compatibility of me equipment and me systems 20
202 Medical electrical equipment Part 1-2.General requirements for basic safety and essential performance Collateral standard. Electromagnetic interference
Requirements and Tests 20
206 Medical electrical equipment Part 1-6.General requirements for basic safety and essential performance Collateral standard. Usability 20
Appendix AA (Informative) Special guidance and rationale 21
Appendix BB (Normative) Production Test 22
Appendix CC (Normative) Document 25
Reference 26
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document is modified to adopt ISO 11197.2019 “Medical supply devices”.
The technical differences between this document and ISO 11197.2019 and their reasons are as follows.
--- Replaced ISO 16571.2014 with the normative reference ISO 16571 (see.201.3,.201.7.2.1.1,.201.7.3,
201.7.9.3), to avoid the impact of international standard updates;
--- Appendix BB is changed from informative to normative (see.201.4.2.3.1 and Appendix BB) to adapt to my country's technical conditions;
--- Added normative reference document GB 50751 (see.201.7.2.1.1) to adapt to my country's technical conditions;
--- Replaced ISO 9170-2.2008 (see.201.7.2.1.1,.201.15.4.104.2) with the normative reference YY/T 0801.2 to apply
According to the technical conditions of our country;
--- Replaced EN62680-1-1.2015 (see.201.7.2.8.2) with the normative reference IEC 62680-1-1.2015 to facilitate the marking
Permitted use;
--- Replaced IEC 60598-1.2014 (see.201.8.1,.201.11.1) with the normative reference GB/T 7000.1 to adapt to my country's
Technical conditions;
--- Replaced ISO 3744.2010 (see.201.9.6) with the normative reference GB/T 3767 to adapt to my country's technical conditions;
--- Replaced ISO 14971.2019 (see.201.13.2.1) with the normative reference GB/T 42062 to adapt to my country's technology
condition;
--- Replaced EN50174-1.2018 with the normative reference EN50174-1 (see.201.15.4.101) to avoid international standards being changed
New impacts;
--- Replaced EN50174-2.2018 with the normative reference EN50174-2 (see.201.15.4.101) to avoid international standards being changed
New impacts;
---Change the structure of the anesthetic gas purification system from "and the gauge pressure can be between 0kPa and 10kPa by design" to "and
The gauge pressure can be between -10kPa and 0kPa by design" (see.201.15.4.102) to adapt to my country's technical conditions;
--- Added the recommended terminal format (see.201.15.4.104.1) to adapt to my country's technical conditions;
--- Replaced IEC 60601-1-2.2014 (see 202) with the normative reference YY9706.102 to adapt to my country's technical conditions;
--- Replaced IEC 60601-1-6.2013 (see 206) with the normative reference YY/T 9706.106 to adapt to my country's technology
condition;
--- The test pressure in Table B is changed to "10 (absolute pressure)" (see Appendix BB) to adapt to my country's technical conditions;
--- Appendix CC is changed from informative to normative (see Appendix BB and Appendix CC) to adapt to my country's technical conditions.
The following editorial changes were made to this document.
--- Replaced IEC 60601-1-2 with informative reference YY9706.102 (see.201.1.3.2);
--- Replaced IEC 60601-1-3.2013 with the informative reference GB 9706.103-2020 (see.201.1.3);
--- IEC 60529.1989 is replaced by the informative reference GB/T 4208 (see.201.5.9.2.3);
--- Replaced EN50174-2.2018 with the informative reference EN50174-2 (see.201.8.10.7);
--- Added the informative reference document DIN13260-2 (see.201.15.4.104.1);
--- Deleted the informative Appendix D "Term Index";
--- Deleted some non-required comments.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Anesthesia and Respiratory Equipment (SAC/TC116).
This document was drafted by. Shanghai Institute of Medical Device Inspection, Nanjing Mindray Bio-Medical Electronics Co., Ltd., Shanghai Draeger Medical
Instrument Co., Ltd. and Sichuan Gangtong Medical Equipment Group Co., Ltd.
The main drafters of this document are. Wang Wei, Ma Xiaojian, Liu Jingwei, Liu Hongbing, Liu Shihai, Yu Hongyi, Li Xinsheng, Lu Guanyong, Chen Jianming, Zhou Zhuang.
Introduction
To facilitate and visualize essential patient care services, many healthcare facilities utilize surface mounted or recessed containment systems and enclosures.
This type of equipment is called a medical supply set.
This document specifies requirements for medical supply sets that are manufactured in the factory or assembled in the field.
This document is intended for personnel involved in the design, manufacture, inspection, testing, maintenance, and operation of healthcare facilities, as well as those who assemble and install medical supply equipment.
For use by designated personnel.
For those involved in the design, manufacture, installation, maintenance and testing of medical gas, medical device gas, vacuum, anesthesia gas purification
It is essential that persons operating equipment for the installation and/or operation of smoke evacuation systems understand the contents of this document.
This document is based on the special standard GB 9706.1-2020.GB 9706.1-2020 is a special standard for general medical and patient environments.
This document also contains basic safety standards for all medical electrical equipment used by qualified persons or under the supervision of qualified persons;
Reliable operation requirements to ensure safety.
GB 9706.1-2020 includes relevant collateral standards and special standards. Collateral standards include requirements for specific technologies and/or hazards.
It applies to all relevant equipment, such as medical systems, electromagnetic compatibility (EMC), radiation protection in X-ray diagnostic equipment, software, etc.
Special standards apply to specific types of equipment, such as medical electron accelerators, high-frequency surgical equipment, hospital beds, etc.
Note. For the definitions of parallel standards and special standards, see GB 9706.1-2020.
For an explanation of the special numbers used in this document and for more information on the terms “parallel,” “special,” and “general” standards, see.201.1.3.
Appendix AA provides a rationale for some of the requirements of this document and is intended to provide further justification for these requirements and the recommendations that have been incorporated into this document.
The clauses and subclauses marked with (*) after the number have corresponding rationale in Appendix AA.
Medical supply equipment
201.1 Scope, purpose and related standards
Chapter 1 of GB 9706.1-2020 applies except for the following parts.
201.1.1 Scope
In GB 9706.1-2020, 1.1 is replaced by the following.
This document specifies particular requirements for the basic safety and essential performance of medical supply sets (also called ME EQUIPMENT).
This document applies to factory-fabricated or field-assembled medical supply units, including cabinets and
Box.
NOTE 1 The party that assembles the various components intended for patient care services into a housing on site is considered the manufacturer of the medical supply set.
Except for 7.2.13 and 8.4.1 of GB 9706.1-2020 (see.201.1.4), the pre-
There are no specific requirements in this document for hazards (sources) caused by the intended functions.
Note 2.See 4.2 of GB 9706.1-2020.
201.1.2 Purpose
In GB 9706.1-2020, paragraph 1.2 is replaced by the following.
The purpose of this document is to establish particular requirements for the basic safety and essential performance of medical supply units as defined in.201.3.201.
201.1.3 Related standards
201.1.3.1 General and parallel standards
1.3 of GB 9706.1-2020 is applicable, and the following contents are added.
This special standard refers to Chapter 2 of the general standard and the applicable parallel standards listed in.201.2 of this special standard.
GB 9706.103, YY9706.108, IEC 60601-1-9, YY/T 9706.110, YY9706.111 and YY9706.112 are not
Be applicable.
Note. Parallel standards are indicated by their standard numbers.
201.1.3.2 Special standards
1.4 of GB 9706.1-2020 is applicable, and the following contents are added.
The numbers of the parts, chapters and clauses in this special standard correspond to GB 9706.1-2020 by adding the prefix "201" (for example,
201.1 corresponds to Chapter 1 of GB 9706.1-2020), or corresponds to the applicable parallel standard by adding the prefix "20×", where ×
It is the last digit of the international standard number of the parallel standard (for example, 202.4 in this special standard corresponds to the parallel standard YY9706.102).
The contents of Chapter 4, 203.4 of this special standard corresponds to the contents of Chapter 4 of the parallel standard GB 9706.103-2020, etc.)
Changes to the text of GB 9706.1-2020 stipulate the use of the following terms.
"Replacement" means that the chapter or article of GB 9706.1-2020 or the applicable parallel standard is completely replaced by the provisions of this special standard.
"Supplement" means that the provisions of this special standard supplement the requirements of GB 9706.1-2020 or applicable parallel standards.
"Modification" means that the chapters or articles of GB 9706.1-2020 or applicable parallel standards are modified by the provisions of this special standard.
The supplementary articles and figures to GB 9706.1-2020 are numbered starting from.201.101.The supplementary appendices are numbered AA, BB, etc.
The project numbers are aa), bb), etc.
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