Recognition List Number: 027 Publication Date: 08/02/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-253: ISO 10535 Second edition 2006-12-15, Hoists for the transfer of disabled persons - Requirements and test methods. (General Plastic Surgery/General Hospital)
Date of Standard: 2006. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
|
SWITZERLAND
|
|
| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB) |
|
| (2) | OFFICE OF DEVICE EVALUATION (ODE) |
|
| (3) | OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL) |
|
|
| Devices Affected: |
| Patient Transfer Devices; both ac-powered and non-ac-powered patient care lifts |
|
| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System Regulation |
|
| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
Complete standard including annexes with the following modifications:
Section 4.3.2.19 shall include the requirement of functional testing to verify the safety of device based on Section 4.3.1.19, not solely determined by verification and inspection.
Section 4.10 Durability
This section references tests and values designed to simulate the ?normal use? of the hoist.
Performance values and number of test cycles to support durability and other performance characteristics of the device should demonstrate, through objective evidence, that risks have been reduced to acceptable levels for the criteria established by the manufacturer. Testing reports should include verification results for each identified design requirement and each element of the design specification. The minimal requirements, including verifiable acceptability criteria, are established to reduce the risk of device failure or patient/user injury to an acceptable level based on the devices intended life cycle.
Additional testing may be necessary for some products. |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.5500 |
Lift, Patient, Ac-Powered |
Class 2 |
FNG |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.5510 |
Lift, Patient, Non-Ac-Powered |
Class 1 |
FSA |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contacts: |
| Alan Stevens |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2561 |
| Silver Spring MD 20993 |
| 301/796-6294 |
| Email: alan.stevens@fda.hhs.gov |
|
| Matthew Schwerin |
| FDA/CDRH/OSEL |
| 10903 New Hampshire Avenue Building 62, Room 2216 |
| Silver Spring MD 20993 |
| 301/563-9114 |
| Email: matthew.schwerin@fda.hhs.gov |
|
| Joan Todd |
| FDA/CDRH/OSB |
| 10903 New Hampshire Avenue Building 66, Room 3118 |
| Silver Spring MD 20993 |
| 301/796-6079 |
| Email: joan.todd@fda.hhs.gov |
|
|
