GB/T 43386-2023Assistive products for personal hygiene that support users - Requirements and test methods (English PDF)
用于支撑使用者的个人卫生辅助器具 要求和试验方法
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Issued by
State Administration for Market Regulation, China National Standardization Administration
Level / Type
National · Recommended
Issue date
November 27, 2023
Implementation date
November 27, 2023
Scope
GB/T 43386-2023 is the English-translated version of 用于支撑使用者的个人卫生辅助器具 要求和试验方法.
GB/T 43386-2023 — This document specifies the requirements and related Test methods, including working environment and safety characteristics of such products: This document specifies the conditions under normal use and foreseeable misuse and safety and performance requirements in the event of failure: This document also specifies methods for measuring the forces required for operational control and specifies some operational the limit of force required: This document applies to the following assistive devices in GB/T 16432-2016: 091203 commode chairs; Note: Includes movable and static products: 091206 Toilet; Note: Toilets with built-in flushers and air dryers are not included: 091209 Toilet seat; 091212 Frame type raised toilet seat; 091215 Built-in raised toilet seat; 091218 Raised toilet seat installed on toilet bowl; 091221 Toilet seat with built-in lifting mechanism to help get up and sit down; 091224 Armrests and backrests fitted to toilet bowls; 091225 Armrests and backrests for floor-standing toilets; 091236 Flushers and air dryers as accessories for toilets; 093303 Bath or shower chairs (with or without wheels), bath seats, stools, backrests and seats; 093312 Bathing beds, shower tables and changing tables; 181506 Height-adjustable stands and brackets; Note: A height-adjustable surface or stand used to place assistive personal hygiene devices (APPH): Can include height-adjustable devices for other items such as basins: 181803 Handrails and support rails; 181806 Fixed grip rails and pull handles; 181810 Removable grab bars and handles; Note: Excludes static movable handrails and handles as defined in 3:27: 181811 Hinged railings and handrails; This document does not include requirements related to: ---Safe installation of building structures; ---Requirements for fixed building facilities, such as water and electricity; ---Bath lift included in ISO 10535; ---GB/T 16432-2016 Bathtub 093321; ---Stability and friction issues related to surface smoothness caused by soap; ---Products customized or specially made for individual users:
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Document preview — GB/T 43386-2023
National Standard of the People's Republic of China
- ICS
- 11.180
- Classification
- C 45
Issued by: State Administration for Market Regulation, China National Standardization Administration
Contents
- Preface
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 General requirements and test methods
- 4.1 Risk Analysis
- 4.2 Expected performance
- 4.3 Clinical evaluation and investigation
- 4.4 Removable personal hygiene aids
- 4.5 Fasteners
- 4.6 Measures to prevent falls
- 4.7 User mass and load limits
- 4.8 Instrument
- 4.9 Test environment
- 5 Materials
- 5.1 General
- 5.2 Flammability
- 5.3 Biocompatibility and toxicity
- 5.4 Infection and microbial contamination
- 5.5 Corrosion resistance
- 6 Sound and Vibration
- 6.1 Noise and vibration
- 6.2 Intensity and frequency of audible alarm devices
- 7 Electromagnetic compatibility
- 7.1 General principles
- 7.2 Launch
- 7.3 Immunity
- 7.4 Power frequency magnetic field immunity
- 8 Electrical Safety
- 8.1 General principles
- 8.2 Electrical system
- 8.3 Security status
- 8.4 Single-failure safety
- 8.5 Continuously active state
- 8.6 Emergency stop function
- 8.7 Continuity of power supply
- 8.8 Battery-operated personal hygiene aids
- 8.9 Circuit Protection
- 8.10 Electric blankets, electric heating pads and similar flexible electric heating appliances
- 8.11 Liquid entry
- 9 Spills, leaks and ingress of liquids
- 9.1 Liquid entry
- 9.2 Spills and leaks
- 10 Temperature of parts in contact with human skin
- 11 Safety of moving and folding parts
- 11.1 Extrusion
- 11.2 Electric lifting movement speed
- 11.3 Mechanical wear
- 11.4 Foot-related movable parts entrapment area
- 12 Prevent the body from being pinched
- 12.1 Holes and gaps
- 12.2 V-shaped opening
- 13 Folding and adjusting mechanism
- 13.1 General principles
- 13.2 Locking device
- 14 Lifting and transport methods
- 14.1 General principles
- 14.2 Requirement
- 14.3 Test Method
- 15 Portable and hand-held personal hygiene products or hand-held parts
- 16 Static strength, impact and durability
- 16.1 General principles
- 16.2 Equation
- 16.3 Number of cycles of durability test
- 16.4 Static strength of lying supports, armrests, footrests, seat cushions and backrests
- 16.5 Durability
- 16.6 Impact
- 17 Stability
- 17.1 Static stability requirements
- 17.2 Static stability test method
- 18 Surfaces, corners, edges and protrusions
- 19 Widgets
- 20 Forces on human soft tissues
- 21 Ergonomics Principles
- 22 Removable APPH
- 22.1 General
- 22.2 Stopping device
- 22.3 Electrical safety of portable APPH
- 22.4 Rough handling and movement
- 22.5 Removable APPH functional requirements
- 22.6 Mobility
- 23 Fixed APPH
- 23.1 General
- 23.2 Requirement
- 23.3 Shower chair(093303)
- 23.4 Bathing beds, shower tables and changing tables (093312)
- 23.5 Bath or shower chairs (without wheels), bath seats, stools, backrests and seats (093303)
- 23.6 Raised toilet seat (091218)
- 23.7 Handrails, and handles (181803 and 181806)
- 23.8 Movable grab bars and handles (181810)
- 23.9 Hinged railings and handrails (181811)
- 23.10 Height-adjustable stands and brackets (181506)
- 24 Static APPH
- 24.1 General
- 24.2 Stability and strength test of static APPH56
- 24.3 Embedded raised toilet seat (non-fixed) (091215)
- 24.4 Toilet seat (non-fixed) with built-in lifting mechanism to assist in getting up and sitting down (091221)
- 24.5 Bath or shower chairs (without wheels), bath seats, stools, backrests and seats (093303)
- 25 Requirements for information from manufacturers
- 25.1 General
- 25.2 Instructions for use
- 25.3 Identification
- 26 Packing
- 27 Inspection Report
- Appendix A (Informative) Cognitive Impairment
- Appendix B (informative) General recommendation
- Appendix C (informative) Environmental and consumer related requirements
- Appendix D (informative) Periodic inspection
- Appendix NA (informative) Chinese documents that have consistent correspondence with the international documents normatively cited in this document
- Reference
- Figure B:1 Example of marking of machine washable APPH72
- Figure B:2 Example of APPH marking for handheld jet/steam cleaning
- Table C:1 CMR chemicals included in the R-term (Annex VI of Directive 67/548/EEC)
- Table C:2 H-CMR chemicals included in the term (Annex I of Regulation No: 1272/2008)
- Table NA:1 Chinese documents that have consistent correspondence with the international documents normatively cited in this document
Foreword
This document complies with the regulations of GB/T 1.1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents" Custom drafting:
This document is equivalent to ISO 17966:2016 "Requirements and test methods for personal hygiene assistive devices used to support users":
This document has made the following minimal editorial changes:
---In 24:5:6:2, "Apply a load in the horizontal backward direction (F2) (see Figure 44)" is changed to "Apply a load in the horizontal backward direction (F2)" (See Figure 43)":
---In 24:5:7:2, "A loading pad (4:8:12:1) should be used to apply a horizontal load of 400N (F1) 10 times at the center of the handrail, see Figure 43, each time A horizontal load should be applied for at least 10 seconds: " is changed to "A loading pad (4:8:12:1) should be used to apply a horizontal load of 400N at the center of the handrail (F1) 10 times, see Figure 44, each horizontal load is applied for at least 10 seconds: "
---Added Appendix NA (informative):
Please note that some content in this document may be subject to patents: The publisher of this document assumes no responsibility for identifying patents:
Introduction
This document specifies the requirements and test methods for personal hygiene aids intended to support the user and intended for use in the home:
care, institution or public place: Some of these products may be used in multiple environments, meaning that different products may be used in different environments:
Requirements and test methods apply to the same product: Chapters 1 to 21 and 25 set out the general requirements for all such products: No:
Chapters 22 to 24 specify special requirements for movable, fixed and static products: These terms are in addition to the general requirements: The product needs to be full Compliance with the requirements of this document can be declared only if all corresponding requirements are met, but this is related to the specific type of product: For example, a product does not contain electricity If there are sub-components, the provisions for the corresponding electronic components may not be required:
Appendix B of this document provides general recommended requirements:
Personal hygiene aids designed to support the user Requirements and test methods
1 Scope
This document specifies the requirements and related Test methods, including working environment and safety characteristics of such products: This document specifies the conditions under normal use and foreseeable misuse and safety and performance requirements in the event of failure: This document also specifies methods for measuring the forces required for operational control and specifies some operational the limit of force required:
This document applies to the following assistive devices in GB/T 16432-2016:
091203 commode chairs;
Note: Includes movable and static products:
091206 Toilet;
Note: Toilets with built-in flushers and air dryers are not included:
091209 Toilet seat;
091212 Frame type raised toilet seat;
091215 Built-in raised toilet seat;
091218 Raised toilet seat installed on toilet bowl;
091221 Toilet seat with built-in lifting mechanism to help get up and sit down;
091224 Armrests and backrests fitted to toilet bowls;
091225 Armrests and backrests for floor-standing toilets;
091236 Flushers and air dryers as accessories for toilets;
093303 Bath or shower chairs (with or without wheels), bath seats, stools, backrests and seats;
093312 Bathing beds, shower tables and changing tables;
181506 Height-adjustable stands and brackets;
Note: A height-adjustable surface or stand used to place assistive personal hygiene devices (APPH): Can include height-adjustable devices for other items such as basins:
181803 Handrails and support rails;
181806 Fixed grip rails and pull handles;
181810 Removable grab bars and handles;
Note: Excludes static movable handrails and handles as defined in 3:27:
181811 Hinged railings and handrails;
This document does not include requirements related to:
---Safe installation of building structures;
---Requirements for fixed building facilities, such as water and electricity;
---Bath lift included in ISO 10535;
---GB/T 16432-2016 Bathtub 093321;
---Stability and friction issues related to surface smoothness caused by soap;
---Products customized or specially made for individual users:
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 85 pages — is available in the English PDF.
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