GB/T 30661.2-2014Wheelchair seating -- Part 2: Determination of physical and mechanical characteristics of devices intended to manage tissue integrity -- Seat cushions (English PDF)

Foreword

GB/T 30661 "wheelchair seat" consists of the following components.

--- Part 1. body parts, body position and posture support surface vocabulary, rules and measurement reference axis;

--- Part 2. maintain tissue integrity physical and mechanical properties measuring device seat;

--- Part 3. postural support means static, impact and fatigue strength measurement;

--- Part 4. seating system for a motor vehicle on;

This section GB/T Part of 230,661.

This section drafted in accordance with GB/T 1.1-2009 given rules.

This section uses the translation method identical with ISO 16840-2:2007 "Wheelchairs Seat - Part 2. maintain tissue integrity means thereof Determination of physical and mechanical properties of the seat cushion. " Consistency correspondence between this part of international documents and normative references of our files are as follows.

--- GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test (ISO 10993-1:2009, IDT)

--- GB/T 18029.26-2014 Wheelchairs terminology (ISO 7176-26:2007, IDT)

--- GB Part 8/T 24218.8-2010 Textiles Nonwovens Test Methods. (simulation of liquid penetration time Urine) (ISO 9073-8:1995, MOD) Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.

This section proposed by the People's Republic of China Ministry of Civil Affairs.

This part of the National Rehabilitation and special equipment Standardization Technical Committee on Persons with Disabilities (SAC/TC148) centralized.

This section drafted by. National Rehabilitation Aids Research Center, National Rehabilitation aids Quality Supervision and Inspection Center, Foshan Dongfang Medical Equipment Co., Ltd., Shanghai Medical Devices Co., Ltd. each state.

Introduction

In the rehabilitation process wheelchair cushion it plays an important role, through the wheelchair seat selection and adaptation to improve wheelchair occupant Sitting support state, and effectively prevent trauma. Upholstery product design and production to meet the different types and degrees of disability who needs unit Sub-products such as wheelchair cushions, it is designed to make it possible bedsore patients with bedsores and maintain the integrity of the organization.

This section describes the test aimed at distinguishing between the different characteristics of the performance of the seat cushion, seat cushion is not suitable for ranking competitions, but also discomfort these features combined will correspond directly to the needs of users. Which referred to the clinical efficacy of implicit, not yet confirmed, it is expected by clinically relevant After the registration department to confirm and revised series of standards. This section describes the physical seat and test method of mechanical properties, this series of standards the other part, the provisions of the heat and water vapor pressure distribution and seat cushion dissipation characteristics.

Wheelchairs Seat - Part 2. maintain tissue integrity Physical and mechanical characteristics of the device measuring seat

1 Scope

This section GB/T 30661 specifies the test equipment used to maintain tissue integrity and tissue trauma prevention of wheelchair seat cushion, measured Test methods and information dissemination requirements. It does not include a seat cushion flame retardancy requirements and test methods. Appendix B provides information on selecting flame retardant Recommendation cushion. This section does not feature specification cushion the contact surface pressure distribution as well as water vapor and heat dissipation characteristics of the seat cushion, in GB/T 30661 in the future will further standardize section.

This section is intended for use as a means to maintain the integrity of the organization other support systems, but also for wheelchair cushions outside.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 131-2006 Geometrical product specifications (GPS) technology products in the surface structure of the file notation (ISO 1302.

2002, IDT)

GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10. irritation and delayed-type hypersensitivity test (ISO 10993-10.2002IDT) ISO 554. 1976 regulation and/or testing standard atmospheric Specification (Standardatmospheresforconditioningand/or testing-Specifications) ISO 7176-26 Wheelchairs - Part 26. Terminology (Wheelchairs-Part 26. Vocabulary) ISO 9073-8:1995 Textiles - Test methods nonwovens - Part 8. Determination of liquid penetration time (simulated urine) [Textiles-Testmethodsfornonwovens-Part 8. Determinationofliquidstrike-throughtime (simula-tedurine)] ISO 10993-1:2003 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and test (Biological evaluationofmedicaldevices-Part 1. Evaluationandtesting) ISO 16840-1:2006 Wheelchair seating - Part 1. body parts, body position and posture support surface vocabulary, rules and reference axis Measurement (Wheelchairseating-Part 1. Vocabulary, referenceaxisconventionandmeasuresforbodyseg-ments, postureandposturalsupportsurfaces) GUM.1993 Guide to the Expression of Uncertainty in Measurement (Guidetoexpressionofuncertaintyinmeasurement, BIPM, IEC , IFCC, ISO , IUPAC, IUPAP, OIML) BS3424-10. 1987 fabric surface coating test methods 12A and 12B. Determination of surface adhesion (Testingcoated fabrics.Methods12Aand12B.Determinationofsurfacedrag) ECERegulation16 motor vehicles and adult seat belt restraint system device, 3rd Edition, Appendix 3, February 27, 1996 (Uniformprovisionsconcerningtheapprovalofsafetybeltsandrestraintsystemsforadultoccupants ofpower-drivenvehicles, Revision3, Amendment3,27February1996) FMVSS209 seat belt assembly (StandardNo.209; SeatBeltAssemblies.FederalMotorVehicle SafetyStandards, 49CFRpart571.209,1October1992)