Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

060

Date of Entry 05/29/2023

FR Recognition Number

6-486

Standard

ISO 10535 Third edition 2021-10
Assistive products - Hoists for the transfer of disabled persons - Requirements and test methods

Scope/Abstract

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FDA recognition of ISO 10535 Second edition 2006-12-15 [Rec# 6-253] will be superseded by recognition of ISO 10535 Third edition 2021-10 [Rec# 6-486].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

FDA/OC/CDRH/OSEL/DAM/

301-563-9114

matthew.schwerin@fda.hhs.gov

Alan Stevens

FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/

301-796-6294

Alan.Stevens@fda.hhs.gov

Standards Development Organization

ISO

International Organization for Standardization