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YY 9706.235-2021: Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
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Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
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YY 9706.235-2021
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PDF similar to YY 9706.235-2021
Basic data | Standard ID | YY 9706.235-2021 (YY9706.235-2021) | | Description (Translated English) | Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C42 | | Word Count Estimation | 54,553 | | Issuing agency(ies) | State Drug Administration | YY 9706.235-2021: Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
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Medical electrical equipment - Part 2-35.Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
ICS 11.040.60
C42
People's Republic of China Pharmaceutical Industry Standards
Replace YY 0834-2011
Medical electrical equipment part 2-35.medical blankets, pads or
Basic safety and basic performance of mattress heating equipment
Dedicated requirements
(IEC 80601-2-35.2009 AMD1.2016CSV,MOD)
Released on 2021-03-09 and implemented on 2023-05-01
Issued by the National Medical Products Administration
Table of contents
Foreword Ⅲ
201.1 Scope, purpose and related standards 1
201.2 Normative references 2
201.3 Terms and Definitions 2
201.4 General requirements 5
201.5 General requirements for testing of ME equipment 5
201.6 Classification of ME equipment and ME systems 5
201.7 ME equipment identification, marking and documentation 6
201.8 Protection of ME equipment against electric shock hazard 8
201.9 Protection of ME equipment and ME systems against mechanical hazards 13
201.10 Protection against unwanted or excessive radiation hazards 14
201.11 Protection against over-temperature and other hazards 14
201.12 Accuracy of controllers and instruments and protection of dangerous outputs 16
201.13 Hazardous Situations and Failure Conditions of ME Equipment 20
201.14 Programmable Medical Electrical System (PEMS) 23
201.15 Structure of ME equipment 23
201.16 ME System 26
201.17 Electromagnetic compatibility of ME equipment and ME systems 26
202 Electromagnetic compatibility---requirements and tests 26
208 General requirements, tests and guidelines for alarm systems in medical electrical equipment and medical electrical systems 27
210 *Development requirements for physiological closed-loop controller 27
Appendix D (informative appendix) Symbols 28
Appendix AA (informative appendix) General guidance and principle explanation 29
Appendix BB (informative appendix) Regulations on insulation materials 39
Appendix CC (Normative Appendix) *Determination of heat conduction to patients 40
Appendix DD (Normative Appendix) *Measurement of heat conduction from the patient 41
Appendix EE (Normative Appendix) Appropriate heat dissipation conditions 42
Appendix FF (Normative Appendix) Test procedure for maximum contact surface temperature of inflatable equipment 43
Appendix GG (Normative Appendix) Test procedure for maximum contact surface temperature of inflatable equipment in a single fault state 44
Appendix HH (Normative Appendix) Safety Test Procedure for Average Contact Surface Temperature of Inflatable Equipment 45
Reference 47
Figure.201.101 The distribution of temperature sensors on the accessible surface of the heating area of the heating device Figure 3
Figure.201.102 Example 3 of temperature sensor distribution on the accessible surface of a heating device with multiple separate heating zones
Figure.201.103 Ignition test device 10
Figure.201.104 Slope 13 for heating mat impact test
Figure.201.105 Partial cover condition 15
Figure.201.106 Folding method of heating blanket 21
Figure.201.107 Folding example 22
Figure.201.108 Wrinkle resistance test test position 26 of heating blanket
Figure AA.1 Illustration of the main requirements of this standard 29
Figure HH.1 Sensor location --- average contact surface temperature 46
Table.201.101 *Supplementary requirements for basic performance 5
Table.201.102 Temperature Limit and Time Relation 24
Foreword
All technical content of this part is mandatory.
The "Medical Electrical Equipment" series of standards is divided into two parts.
---Part 1.General and parallel requirements;
---Part 2.Special requirements.
This part is part 2-35.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY 0834-2011 "Medical Electrical Equipment Part 2.Medical electric blankets, electric heating pads and electric mattresses for safety
Requirements'', compared with YY 0834-2011, the main technical changes except for editorial changes are as follows.
---Modified the scope of application of the standard (see.201.1.1, 1.1 of YY 0834-2011);
---Added some terms and definitions (see.201.3.204,.201.3.205,.201.3.206,.201.309,.201.3.210,.201.3.211,
201.3.214,.201.317);
---Added basic performance (see.201.4.
---Added the risk control measures or test methods for ME equipment or ME system substitution (see.201.4.5);
---The combination of equipment has been added (see.201.4.101);
---Added ME equipment identification, marking and documentation (see.201.7);
---Modified the protective measures for patients; (see.201.8.5.1.2, Chapter 17 of YY 0834-2011)
--- Increased the mechanical hazards related to the support system (see.201.9.8);
---Modified the protection against over-temperature and other hazards (see Chapter.201.11, Chapter 42 of YY 0834-2011);
---Modified the power supply/power supply network interruption of ME equipment (see.201.11.8, Chapter 49 of YY 0834-2011);
---Modified the accuracy of the controller and the instrument and the protection of dangerous output (see.201.12, Chapter 50, Chapter YY 0834-2011
Chapter 51);
---Modified the hazard situation and failure conditions of ME equipment (see.201.13, Chapter 52 of YY 0834-2011);
---Modified the structure of ME equipment (see.201.15, Chapter 54 and Chapter 56 of YY 0834-2011);
---Modified the electromagnetic compatibility requirements (see 202, Chapter 36 of YY 0834-2011);
---Additional requirements for the termination of inactive alarm signal (see 208.6.8.4.101).
This part uses the redrafting law to amend and adopt the international standard IEC 80601-2-35.2009 AMD1.2016 CSV "Medical Electrical Equipment"
Part 2-35.Special requirements for the basic safety and basic performance of medical blanket, pad or mattress heating equipment.
The technical differences between this part and IEC 80601-2-35.2009 AMD1.2016CSV and the reasons are as follows.
---Regarding normative reference documents, this section has made adjustments with technical differences to adapt to my country's technical conditions and adjustments.
The situation is collectively reflected in.201.2 "Normative Reference Documents", and the specific adjustments are as follows.
● Replace IEC 60601-1-2 with YY 9706.102 modified to adopt international standards;
● Replace IEC 60601-1-8 with YY 9706.108 modified to adopt international standards;
● Replace IEC 60601-1-10 with YY/T 9706.110 modified to adopt international standards;
● Deleted ISO 14971.2007, because the standard is not cited in the main text;
● ISO 2439.2008 was deleted because the standard was not cited in the main text.
--- Deleted the temperature control setting mark unit "degreeC", only keep "℃" [see.201.7.4.2.101,.201.12.1.101.2c)],
Consistent with the International System of Units.
--- Deleted "through the transformer" (see.201.8.1), taking into account whether the heating equipment is isolated from the grid power supply through the transformer and.201.8.
The risk of a single failure state described by the third dash is irrelevant.
---Modify IEC 60083 to GB/T 1002 (see.201.15.4.1.101), in line with my country's regulations on the types of power plugs and sockets for the grid
To avoid incorrect connection to the network power supply.
This section has made the following editorial changes.
--- Modify the translations of.201.1.3 and.201.1.4 to be consistent with domestic standards;
---Delete references, correspondingly delete the note in "normative references" (see.201.2);
--- Delete the index of terms and definitions, correspondingly delete the note in "Terms and Definitions" (see.201.3);
--- Modify the titles of.201.4.5 and.201.14.13 to be consistent with the general standard;
--- Modify the misuse of terms in the original text [see.201.7.2.1.101.1e),.201.11.1.2.1.101.3,.201.13.1.2.101.5,.201.15.4.103];
---Fixed the error of international document reference numbers (see.201.8.8.4.101,.201.12.4.105,.201.13.1.2.101.3, Appendix AA
(In clause.201.7.2.1.101, clause.201.11.1.2.1.102.3, clause.201.15.4.2.1.101);
--- Amend the misused term "heating equipment" to "applied part" [see.201.7.9.2.9.102,.201.13.1.2.101.5, Appendix CC
d)] to distinguish it from "heating equipment" including "controller";
---"See the explanation of principle" is amended to "See Appendix AA General Guidelines and Explanation of Principles" (see.201.11.2,.201.11.8.101,.201.14.13),
To be consistent with the appendix title;
---In order to facilitate understanding, editorial changes are made during translation (see.201.12.3.103,.201.12.3.104, Table.201.102);
--- Amend the 202.6 clause number to be consistent with domestic standards.
Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This part was proposed by the State Drug Administration.
This part is under the jurisdiction of the National Medical Electrical Appliance Standardization Technical Committee Physical Therapy Equipment Subcommittee (SAC/TC10/SC4).
Drafting organizations of this section. Tianjin Medical Device Quality Supervision and Inspection Center, Beijing Medical Device Technology Evaluation Center, Beijing Hengbang Branch
Technology Development Co., Ltd., Jiangmen Dacheng Medical Equipment Co., Ltd.
The main drafters of this section. Zhang Yun, Zhang Haiming, Qian Xuebo, You Yijie, Chen Ran, Gong Yuxiang, Deng Hui, Chen Zhi.
The previous releases of the standards replaced by this part are as follows.
---YY 0834-2011.
Medical electrical equipment part 2-35.medical blankets, pads or
Basic safety and basic performance of mattress heating equipment
Dedicated requirements
201.1 Scope, purpose and related standards
In addition to the following, Chapter 1 of the general standard applies.
201.1.1 *Scope
replace.
This Part specifies the basic safety and basic performance of medical blanket, pad or mattress heating equipment, which is medical electrical equipment (
(Hereinafter referred to as ME equipment).
This section applies to medical blanket, mat or mattress heating equipment, including heating equipment intended to preheat the bed.
If the chapter or article clearly states that it is only applicable to ME equipment or medical electrical systems (hereinafter referred to as ME system), the title and text of the chapter or article
Will explain. If not stated, this chapter or article applies to both ME equipment and ME systems.
If the chapter or article clearly states that it is applicable to a specific type of ME equipment, such as inflatable equipment, the title of the chapter or article will be indicated. Apply to this
The chapters or articles of all types of ME equipment in some areas will not be specifically noted.
In addition to 7.2.13 and 8.4.1 of the general standard, the expected physiological effects of the ME equipment or ME system within the scope of this part are caused by
Hazards are not included in the specific requirements of this section.
Note 1.See 4.2 of the General Standard.
Note 2.Some clauses are annotated in the "General Guidelines and Principles" section, see Appendix AA. Clauses or sub-clauses corresponding to the notes in Appendix AA
The models are marked with an asterisk (*).
This section does not apply to.
--- Heating equipment intended for physical therapy;
---Infant radiant warmer, see YY 0455;
---Infant incubator, see GB 11243;
---Transport incubator, see YY 9706.220;
---Cooling equipment.
201.1.2 Purpose
replace.
The purpose of this section is to establish specific requirements for basic safety and basic performance, and to minimize the use of heating blankets, heating pads or heating beds
Cushion and heating equipment used for medical purposes pose a hazard to patients and operators, and stipulate test methods to prove compliance.
201.1.3 Parallel standards
supplement.
This section refers to Chapter 2 of the General Standards and applicable parallel standards listed in.201.2 of this section.
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