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BS ISO 17966:2016 Assistive products for personal hygiene that support users. Requirements and test methods, 2016
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 General requirements and test methods
- 4.1 Risk analysis
- 4.2 Intended performance
- 4.3 Clinical evaluation and investigation
- 4.4 Assistive products for personal hygiene that can be dismantled
- 4.5 Fasteners
- 4.6 Means to prevent falling out
- 4.7 User mass/load limits
- 4.8 Apparatus
- 4.9 Test conditions
- 5 Materials
- 5.1 General
- 5.2 Flammability
- 5.2.1 General
- 5.2.2 Moulded parts used as enclosures for electrical equipment
- 5.2.3 Upholstered parts and moulded parts
- 5.3 Biocompatibility and toxicity
- 5.4 Infection and microbiological contamination
- 5.4.1 Cleaning and disinfection
- 5.4.2 Resistance against temperature alternations
- 5.4.3 Animal tissue
- 5.5 Resistance to corrosion
- 6 Emitted sound and vibration
- 6.1 Noise and vibration
- 6.2 Sound pressure levels and frequencies of audible warning devices
- 7 Electromagnetic compatibility
- 7.1 General
- 7.2 Emissions
- 7.3 Immunity
- 7.4 Power frequency magnetic field immunity
- 8 Electrical safety
- 8.1 General
- 8.2 Electrical systems
- 8.3 Safe positioning
- 8.4 Single fault safety
- 8.5 Hold to run activation
- 8.6 Emergency stopping functions
- 8.7 Continuity of power supply
- 8.8 Battery powered assistive products for personal hygiene
- 8.8.1 Battery housings
- 8.8.2 Connection
- 8.8.3 Charge level indicator
- 8.9 Circuit protection
- 8.10 Electrically heated blankets, pads and similar flexible heating appliances
- 8.11 Ingress of liquids
- 9 Overflow, leakage, and ingress of liquids
- 9.1 Ingress of liquids
- 9.1.1 Requirements
- 9.1.2 Test method
- 9.2 Overflow and leakage
- 9.2.1 General
- 9.2.2 Substances which may leak from an APPH in intended use and in fault conditions
- 10 Temperatures of parts that come in contact with human skin
- 11 Safety of moving and folding parts
- 11.1 Squeezing
- 11.2 Velocity of powered lifting and lowering movements
- 11.2.1 Requirements
- 11.2.2 Test method
- 11.3 Mechanical wear
- 11.4 Trapping zones for feet in relation to moving parts
- 12 Prevention of traps for parts of the human body
- 12.1 Holes and clearances
- 12.2 V-shaped openings
- 13 Folding and adjusting mechanisms
- 13.1 General
- 13.2 Locking mechanisms
- 14 Lifting and carrying means
- 14.1 General
- 14.2 Requirement
- 14.3 Test method
- 15 Portable and hand-held products for personal hygiene or hand-held parts
- 16 Static strength, impact and durability
- 16.1 General
- 16.2 Formulae
- 16.2.1 Formulae for calculating forces
- 16.3 Number of test cycles for durability
- 16.4 Static strength of lying support, arm and foot supports and seat and back surfaces
- 16.4.1 Requirements
- 16.4.2 Test methods
- 16.5 Durability
- 16.5.1 Requirements
- 16.5.2 Test methods
- 16.6 Impact
- 16.6.1 Requirements
- 16.6.2 Test methods
- 17 Stability
- 17.1 Requirements for static stability
- 17.2 Test method for static stability
- 18 Surfaces, corners, edges and protruding parts
- 19 Small parts
- 20 Forces in soft tissues of the human body
- 21 Ergonomic principles
- 22 Mobile APPHs
- 22.1 General
- 22.2 Immobilizing means
- 22.2.1 General
- 22.2.2 Requirements for locking devices
- 22.2.3 Test methods for locking devices
- 22.2.4 Test methods for durability of brakes
- 22.2.5 Brake operated by a lever
- 22.3 Electrical safety for mobile APPHs
- 22.3.1 Power-driven mobile APPHs
- 22.4 Rough handling and movement
- 22.4.1 General
- 22.4.2 Requirements
- 22.4.3 Test method for movement over a threshold
- 22.4.4 Test method for door frame shock
- 22.5 Functional requirements for mobile APPHs
- 22.5.1 Foot supports
- 22.5.2 Position of push handles/points
- 22.5.3 Turning diameter of mobile APPHs
- 22.6 Moving forces
- 22.6.1 Requirements for moving forces
- 22.6.2 Test methods for moving forces
- 23 Fixed APPHs
- 23.1 General
- 23.2 Requirements
- 23.3 Shower seats (09 33 03)
- 23.3.1 Description
- 23.3.2 Test methods for static strength, durability and impact for shower seats
- 23.4 Bathing stretchers, shower tables and diaper changing tables (09 33 12)
- 23.4.1 Description
- 23.4.2 Test methods for static strength and durability for bathing stretchers, shower tables and diaper changing tables
- 23.5 Bath/shower chairs (without wheels), bath boards, stools, back supports and seats (09 33 03)
- 23.5.1 Description
- 23.5.2 Test method for durability
- 23.6 Raised toilet seats (09 12 18)
- 23.6.1 Description
- 23.6.2 Requirements for static strength for raised toilet seats
- 23.6.3 Test methods for static strength and durability for raised toilet seats
- 23.7 Handrails, grab bars and handgrips (18 18 03 and 18 18 06)
- 23.7.1 Description
- 23.7.2 Ergonomic principles for handrails, grab bars and handgrips
- 23.7.3 Test methods for static strength and durability for handrails, grab bars and handgrips
- 23.8 Removable grab rails and handgrips (18 18 10)
- 23.8.1 Description
- 23.8.2 Ergonomic principles for removable grab rails and handgrips
- 23.8.3 Test methods for static strength and durability for removable grab rails and handgrips
- 23.9 Hinged rails and arm supports (18 18 11)
- 23.9.1 Description
- 23.9.2 General
- 23.9.3 Test method for static strength for hinged rails and arm supports
- 23.10 Height-adjustable plinths and brackets (18 15 06)
- 23.10.1 Description
- 23.10.2 Test methods for static strength and durability for height-adjustable plinths and brackets
- 24 Static APPHs
- 24.1 General
- 24.2 Stability and strength tests for static APPHs
- 24.3 Toilet seats inserts (non fixed) (09 12 15)
- 24.3.1 Description
- 24.3.2 Impact
- 24.4 Toilet seats with built-in raising mechanism to help standing up and sitting down (non-fixed) (09 12 21)
- 24.4.1 Description
- 24.4.2 Durability
- 24.5 Bath/shower chairs (without wheels), bath boards, stools, back supports and seats (09 33 03)
- 24.5.1 Description
- 24.5.2 Materials
- 24.5.3 Stability
- 24.5.4 Stability tests for APPHs designed to be supported by the sides of a bathtub
- 24.5.5 Strength test of brackets
- 24.5.6 Friction test of bath board/seat
- 24.5.7 Static horizontal force test on handle
- 24.5.8 Static vertical force test of handle of bath and transfer boards
- 25 Requirements for information supplied by the manufacturer
- 25.1 General
- 25.2 Instructions for use
- 25.2.1 Pre-sale information
- 25.2.2 User information
- 25.2.3 Service information
- 25.3 Labelling
- 26 Packaging
- 27 Test report
- Annex A (informative) Cognitive impairment
- Annex B (informative) General recommendations
- Annex C (informative) Environmental and consumer-related requirements
- Annex D (informative) Periodic inspection
- Bibliography [Go to Page]