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GB 9706.283-2022: Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
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Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
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GB 9706.283-2022
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Basic data | Standard ID | GB 9706.283-2022 (GB9706.283-2022) | | Description (Translated English) | Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment | | Sector / Industry | National Standard | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 30,361 | | Date of Issue | 2022-12-29 | | Date of Implementation | 2026-01-01 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB 9706.283-2022: Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
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ICS 11.040.60
CCSC40
National Standards of People's Republic of China
Medical Electrical Equipment Part 2-83.Household Phototherapy
Particular requirements for basic safety and essential performance of equipment
(IEC 60601-2-83.2019, MOD)
Released on 2022-12-29
2026-01-01 Implementation
State Administration for Market Regulation
Released by the National Standardization Management Committee
table of contents
Preface III
Introduction V
201.1 Scope, purpose and related criteria1
201.2 Normative references 2
201.3 Terms and Definitions 2
201.4 General requirements 4
201.5 General requirements for testing of ME EQUIPMENT 4
201.6 Classification of me equipment and me systems4
201.7 ME EQUIPMENT IDENTIFICATION, MARKING AND DOCUMENTATION 6
201.8 Protection against electric shock hazards for ME EQUIPMENT8
201.9 Protection against mechanical hazards by ME EQUIPMENT and ME SYSTEMS 8
201.10 Protection against unwanted or excessive radiation hazards (sources)8
201.11 Protection against extreme temperatures and other hazards (sources) 10
201.12 Accuracy of controls and instruments and protection against hazardous outputs 10
201.13 ME EQUIPMENT HAZARDOUS CONDITIONS AND FAULT CONDITIONS 10
201.14 Programmable electrical medical systems (PEMS) 10
201.15 Construction of ME EQUIPMENT 10
201.16 ME system 10
201.17 Electromagnetic compatibility of me equipment and me systems11
202 Electromagnetic disturbance requirements and tests 11
206 Availability 11
211 Requirements for ME EQUIPMENT and ME SYSTEMS used in the home care environment 11
Appendix 13
Appendix C (informative) Guiding requirements for marking and marking of me equipment and me systems 14
Appendix D (Informative) Symbols 17
Appendix AA (Informative) Special Guidelines and Principles 19
Appendix BB (informative) Protective glasses for household phototherapy equipment 21
Reference 22
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 part 2-83 of GB 9706 "Medical Electrical Equipment". GB 9706 has released the following parts.
--- Part 1.General requirements for basic safety and essential performance;
--- Part 1-3.General requirements for basic safety and essential performance Collateral standard. Radiation protection of diagnostic X-ray equipment;
--- Part 2-1.Particular requirements for the basic safety and essential performance of electron accelerators with energies ranging from 1 MeV to 50 MeV;
--- Part 2-2.Special requirements for basic safety and basic performance of high-frequency surgical equipment and high-frequency accessories;
--- Part 2-3.Special requirements for basic safety and basic performance of short-wave therapy equipment;
--- Part 2-4.Particular requirements for basic safety and basic performance of cardiac defibrillators;
--- Part 2-5.Particular requirements for basic safety and basic performance of ultrasonic physiotherapy equipment;
--- Part 2-6.Particular requirements for basic safety and basic performance of microwave therapy equipment;
--- Part 2-8.Particular requirements for basic safety and essential performance of therapeutic X-ray equipment with energy from 10kV to 1MV;
--- Part 2-11.Particular requirements for basic safety and essential performance of gamma beam therapy equipment;
--- Part 2-12.Particular requirements for basic safety and basic performance of critical care ventilators;
--- Part 2-13.Special requirements for basic safety and basic performance of anesthesia workstations;
--- Part 2-16.Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment;
--- Part 2-17.Particular requirements for basic safety and basic performance of automatically controlled brachytherapy afterloading equipment;
--- Part 2-18.Particular requirements for basic safety and essential performance of endoscopic equipment;
--- Part 2-19.Particular requirements for basic safety and basic performance of infant incubators;
--- Part 2-22.Special requirements for basic safety and essential performance of laser equipment for surgery, plastic surgery, therapy and diagnosis;
--- Part 2-24.Particular requirements for basic safety and essential performance of infusion pumps and infusion controllers;
--- Part 2-25.Specific requirements for basic safety and basic performance of electrocardiographs;
--- Part 2-26.Special requirements for basic safety and basic performance of EEG machines;
--- Part 2-27.Special requirements for basic safety and basic performance of ECG monitoring equipment;
--- Part 2-28.Particular requirements for basic safety and essential performance of medical diagnostic X-ray tube assemblies;
--- Part 2-29.Particular requirements for basic safety and basic performance of radiotherapy simulators;
--- Part 2-36.Particular requirements for the basic safety and essential performance of in vitro induced lithotripsy equipment;
--- Part 2-37.Particular requirements for basic safety and essential performance of ultrasonic diagnostic and monitoring equipment;
--- Part 2-39.Particular requirements for basic safety and basic performance of peritoneal dialysis equipment;
--- Part 2-43.Particular requirements for basic safety and essential performance of X-ray equipment for interventional operation;
--- Part 2-44.Particular requirements for basic safety and essential performance of X-ray computed tomography equipment;
--- Part 2-45.Particular requirements for basic safety and basic performance of mammography equipment and mammography stereotaxic devices;
--- Part 2-54.Particular requirements for basic safety and essential performance of X-ray photography and fluoroscopy equipment;
--- Part 2-55.Particular requirements for basic safety and basic performance of respiratory gas monitors;
--- Part 2-60.Particular requirements for basic safety and essential performance of dental equipment;
--- Part 2-63.Particular requirements for basic safety and basic performance of dental X-ray machines for extraoral imaging;
--- Part 2-65.Particular requirements for basic safety and basic performance of dental X-ray machines for intraoral imaging;
--- Part 2-71.Particular requirements for basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment;
--- Part 2-75.Particular requirements for basic safety and essential performance of photodynamic therapy and photodynamic diagnostic equipment;
--- Part 2-83.Particular requirements for the basic safety and essential performance of household phototherapy equipment;
--- Part 2-90.Particular requirements for basic safety and essential performance of high-flow respiratory therapy equipment.
This document is modified to adopt IEC 60601-2-83.2019 "Medical Electrical Equipment Part 2-83.Basic Safety of Household Light Therapy Equipment
and Basic Performance Specific Requirements".
Compared with IEC 60601-2-83.2019, this document has made the following structural adjustments.
---202.6.2.1.10 corresponds to 202.8 in IEC 60601-2-83.2019.
The technical differences between this document and IEC 60601-2-83.2019 and their reasons are as follows.
--- Replaced ISO 15223-1.2016 with the normatively referenced YY/T 0466.1-2016 (see.201.2,.201.7.2.13,
211.8.3.1, Appendix D), to adapt to my country's national conditions;
--- Replaced ISO 3864-1.2011 with the normative reference GB/T 2893.1-2013 (see.201.2, Appendix D), between the two documents
The degree of consistency among them is modified to suit my country's national conditions;
--- Replaced IEC 60601-1.2012 with the normative reference GB 9706.1-2020 (see.201.1.4,.201.2,.201.7.2.3,
211.8.3.1), the degree of consistency between the two documents is modified to suit my country's national conditions;
--- Replaced IEC 60601-1-2.2014 with normative reference YY9706.102-2021 (see.201.1.3,.201.1.4,.201.2,
201.3, 202), in order to adapt to my country's national conditions;
--- Replaced IEC 60601-1-6.2013 with the normatively referenced YY/T 9706.106-2021 (see.201.1.3,.201.2,.201.3,
206), the degree of consistency between the two documents is modified to suit my country's national conditions;
--- Replaced IEC 60601-1-11.2015 with normative reference YY9706.111-2021 (see.201.1.3,.201.2,.201.3,
211), the degree of consistency between the two documents is modified to suit my country's national conditions;
--- Replaced IEC 62471-1.2016 with the normative reference GB/T 20145-2006 (see.201.2,.201.6,.201.10.105,
"Clause.201.3.201 Acceptance Angle γ/Clause.201.3.202 Opposite Angle α" of Appendix AA, "Clause.201.6.101 of Appendix AA
Optical Radiation Protection") to adapt to the national conditions of our country.
The following editorial changes have been made to this document.
--- Add "201.7.9.2.2.101 warning and
Note that the content of the statement may be replaced by other statements expressing the same meaning";
--- Changed "References";
--- Deleted the "index of term definitions".
Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed and managed by the State Drug Administration.
Introduction
Safety standards for medical electrical equipment, also known as the 9706 series of standards, consist of general standards, collateral standards, specific standards, guidelines and interpretations.
---General standard. The safety standard that medical electrical equipment should be generally applicable, that is, the equipment that meets the definition of medical electrical equipment should meet this
Basic standard requirements.
--- Parallel standards. safety standards that should be generally applicable to medical electrical equipment, but in most cases are limited to certain specific functions or special
It is only the equipment that needs to meet the requirements of such standards.
---Special standards. Safety standards applicable to a certain type of medical electrical equipment, and not all medical electrical equipment have specific standards
standard.
---Guidelines and interpretations. explanations for the application guidelines and clauses of the relevant requirements in the standards involved.
In the GB 9706 series of standards, in addition to the published standards and this document, the planned standards are as follows.
--- Part 2-66.Particular requirements for basic safety and essential performance of hearing devices and hearing device systems. The purpose is to build listening
Particular requirements for basic safety and essential performance of equipment and hearing device systems.
This document deals with the basic safety and essential performance requirements for home-use phototherapy equipment. This document modifies and supplements GB 9706.1-2020
"Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Essential Performance".
Items marked with an asterisk (*) in this document have specific guidelines and rationale related to the project in Appendix AA. Appendix AA
Relevant content not only contributes to the correct application of this document, but also speeds up the revision of the standard due to changes in clinical practice or technical development in a timely manner.
standard process.
Medical Electrical Equipment Part 2-83.Household Phototherapy
Particular requirements for basic safety and essential performance of equipment
201.1 Scope, purpose and relevant standards
Except as described below, Chapter 1 of the general standard applies.
201.1.1 Scope
replace.
This document applies to the basic safety and essential performance of home light therapy equipment used in the home care environment. home light therapy equipment
Often used by inexperienced operators.
The scope of this document includes all light sources except lasers.
If a chapter or clause applies only to me equipment or me systems, the title and content of the chapter or clause will clearly state this. no
Then, this clause or subclause applies to both ME EQUIPMENT and ME SYSTEMS.
201.1.2 Purpose
replace.
The purpose of this document is to specify specific requirements for the basic safety and essential performance of home-use phototherapy equipment.
201.1.3 Collateral Standards
Supplement.
This document refers to Chapter 2 of the General Standard as well as applicable collateral standards listed in Section.201.2 of this part.
Chapter 202, Chapter 206 and Chapter 211 of YY9706.102-2021, YY/T 9706.106-2021 and YY9706.111-2021
Chapter modifications apply. GB 9706.103, YY9706.108, YY9706.110 and YY9706.112 are not applicable. All GB 9706 series
Other published collateral standards are applicable to published standards.
201.1.4 Particular standards
Supplement.
In the GB 9706 series, the specific standards can modify, replace or delete the general standards and parallel standards according to the special me equipment under consideration.
requirements contained in the standards. And other basic safety and basic performance requirements may be supplemented.
The requirements of a particular standard take precedence over those of a general standard.
In this document, GB 9706.1-2020 is referred to as the general standard. Collateral standards are indicated by their respective document numbers.
The prefix "201" before the number of chapters and clauses in this document corresponds to the general standard (for example,.201.1 in this document corresponds to the first part of the general standard
Chapter), or add the prefix "20×" to correspond to the applicable collateral standard, where × is the last digit of the international standard number corresponding to the collateral standard (for example
For example, 202.4 in this document corresponds to the contents of Chapter 4 in the collateral standard YY9706.102-2021, and 203.4 in this document corresponds to the collateral standard
Contents of Chapter 4 of GB 9706.103-2020, etc.).
Changes to the text of the general standard are regulated by the use of the following words.
"Replace" means that the chapter or clause of the general standard or applicable collateral standard is completely replaced by the content of this document.
"Supplement" means that the content of this document is supplemented by the general standard or applicable collateral standard.
"Modification" means that the chapter or clause of the general standard or the applicable collateral standard is modified by the content of this document.
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