GB/T 19545.1-2012Walking aids manipulated by one arm -- Requirements and test methods -- Part 1: Elbow crutches (English PDF)

Foreword

GB/T 19545 "arm mobility aids, devices operating requirements and test methods" has the following components.

--- Part 1. Elbow crutches;

--- Part 2. axillary Abduction;

--- Part 4. tripod foot or cane.

This section GB/T 19545 Part 1.

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

This Part replaces GB/T 19545.1-2004 "operating arm walker technical requirements and test methods - Part 1. Elbow crutches." Section compared with the GB/T 19545.1-2004 The main changes are as follows.

--- Modifications and additions some of the terms and definitions (see Chapter 3, Chapter 3, 2004 edition);

--- Revised test methods test sequence (see Chapter 5, Chapter 5, 2004 edition);

--- Increased forearm Escape test and handle separation test (see 5.4 and 5.5);

--- Modify the static load test, fatigue test geometry load requirements (see 56, 2004. Version 5.5.);

--- Modify the information supplied by the manufacturer (see Chapter 6, 2004 edition Chapter 6);

--- Modify the test reporting requirements (see Chapter 7, Chapter 7, 2004 edition);

--- Increase the informative appendix (see Appendix A, 2004 edition 4.1.2,4.1.3,4.1.5,4.2.2,4.2.4,4.3.1,4.4.3, 4.5,4.6,4.7,4.8.5).

This section uses the translation method identical with ISO 11334-1:2007 "operating arm walking aids - Requirements and test methods - Part 1.

Elbow crutches. "

Correspondence between the consistency of the standards of international documents and normative references of our files.

--- GB/T 16432-2004 aids for disabled persons - Classification and terminology (ISO 9999:2002, IDT).

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 is responsible for drafting. National Rehabilitation Device Quality Supervision and Inspection Center, Shanghai Hubang Medical Devices Co., Ltd., Foshan Oriental Medicine Spa Equipment Co., Ltd., China Rehabilitation Research Center.

1 Scope

GB/T 19545 in this section specifies the requirements and test methods fitted with handles and legs elbow crutches, provides for separation of elbow crutches, Test methods for static load, fatigue and low temperature.

GB/T 19545 in this section also gives security, human parameters, performance, manufacturers provide information (including marking and labeling) related Claim.

This section requirements and test methods based on maximum user weight specified by the manufacturer, elbow crutches or walking in everyday use swing.

GB/T 19545 in this section apply to the user's body weight less than 35kg elbow crutches.

This section feet walking surface friction with respect to the requirements and test methods do not involve.

NOTE. Additional Explanation See Addendum GB/T 19545 in this section A.

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.

ISO 9999 aids for disabled persons - Classification and terminology (Assistiveproductsforpersonswithdisability-Classificationandterminology) EN1041 medical device manufacturers to provide information (Informationsuppliedbythemanufacturerwithmedical devices)

3 Terms and Definitions

The following terms and definitions apply to this document.

Elbow crutches elbowcrutch One leg, with handles and non-horizontal forearm support mobility aids, devices, see Figure 1.

Note. According to ISO 9999, classification code is 120306.

Grip handle

Connecting the handle portion elbow crutches.

Handle handgrip

Elbow crutches use for hand held portion of Figure 1 in 5.

Handle length handgriplength from the lowest point on the surface of the handle closest to the front end, to the lowest point on the surface of the handle closest to the rear end of the handle, the axial dimension measured,