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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 060 Date of Entry 05/29/2023 
FR Recognition Number 6-486
ISO  10535 Third edition 2021-10
Assistive products - Hoists for the transfer of disabled persons - Requirements and test methods
ISO 10535:2021 specifies requirements and test methods only for hoists and body-support units intended for the transfer of persons with disabilities. The document applies to the following products classified in ISO 9999:2022:
- 12 36 03 Mobile hoists for transferring a person in sitting position with sling seats;
- 12 36 04 Mobile hoists for transferring a person in standing position;
- 12 36 06 Mobile hoists for transferring a person in sitting position with solid seats;
- 12 36 09 Mobile hoists for transferring a person in lying position;
- 12 36 12 Stationary hoists fixed to walls, floor or ceiling;
- 12 36 15 Stationary hoists fixed to, or mounted in or on, another product;
- 12 36 18 Stationary free-standing hoists;
- 12 36 21 Body-support units for hoists.
This document covers different types of mobile and stationary hoists. Some of the requirements and test methods are general and others are only valid for specific product types.
Annexes A, B and C provide general recommendations.
This document does not apply to devices that transport persons between two levels (floors) of a building.
It does not include methods for the determination of ageing or corrosion of such hoists and units.
It does not include methods to qualify individual units prior to use.
The requirements of this document are formulated with regard to the needs of both the persons being hoisted and the attendant using the hoist.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ISO 10535 Second edition 2006-12-15 [Rec# 6-253] will be superseded by recognition of ISO 10535 Third edition 2021-10 [Rec# 6-486]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-253] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 6-253] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5500 Lift, Patient, Ac-Powered Class 2 FNG
§880.5510 Lift, Patient, Non-Ac-Powered Class 1 FSA
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Matthew Schwerin
 Alan Stevens
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.