GB 22457-2008 English PDFUS$629.00 · In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email. GB 22457-2008: Service of fitting prosthesis Status: Valid
Basic dataStandard ID: GB 22457-2008 (GB22457-2008)Description (Translated English): Service of fitting prosthesis Sector / Industry: National Standard Classification of Chinese Standard: C45 Classification of International Standard: 11.040.40 Word Count Estimation: 27,243 Date of Issue: 2008-09-19 Date of Implementation: 2009-03-01 Quoted Standard: GB/T 191; GB/T 9174; GB/T 13461; GB/T 14191; GB 14722; GB/T 15721.1; GB/T 15721.2; GB/T 15721.3; GB/T 16432 Regulation (derived from): Announcement of Newly Approved National Standards No. 17 of 2008 (No. 130 overall) Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China Summary: This Chinese standard specifies the prosthetic configuration process Reception, checks, prescriptions issued, the configuration Agreement, the preservation of records and configuration protocol, preparatory work prior to assembly, production, use of training, assembly quality inspection, delivery, logo, packaging, transportation, storage, follow-up and other service requirements. This standard applies to all kinds of institutions engaged in prosthetics. GB 22457-2008: Service of fitting prosthesis---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.Service of fitting prosthesis ICS 11.040.40 C45 National Standards of People's Republic of China Prosthetic Configuration Service Posted 2008-09-19 2009-03-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released Table of ContentsIntroduction Ⅲ Introduction Ⅳ 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 1 General 5 System Construction 2 2 6 prosthetic configuration General requirements 7 prosthetic delivery 4 8 signs, packaging, transportation, storage 5 9 Follow-up 5 Appendix A (normative) prosthetic configuration medical home 6 Appendix B (normative) prosthetic Configuration Checklist 7 Annex C (normative) prosthetic size measurement configuration record 8 Annex D (normative) configuration prosthetic prescription 17 Annex E (informative) 18 prosthetic Configuration Protocol Annex F (informative) prosthetic warranty card configuration 19 Annex G (informative) prosthetic instructions to configure the product 20 Annex H (normative) configuration prosthetic follow-up record table 21ForewordChapter 6 of this standard are mandatory, the rest are recommended. The Standard Appendix A, Appendix B, Appendix C, Appendix D and Appendix H of normative appendix, Appendix E, Appendix F and Appendix G of data Appendix. The standard proposed by the People's Republic of China Ministry of Civil Affairs. This standard by the national rehabilitation and special equipment Standardization Technical Committee on Persons with Disabilities (SAC/TC148) centralized. Drafting of this standard. National Research Center for Rehabilitation Technical Aids, China Rehabilitation Research Center, Beijing Jing Bo modern orthopedic technology Ltd., Shanghai Co., Ltd. Jing Bo orthopedic, prosthetic rehabilitation research center in Zhejiang Province, Beijing orthopedic technology center. The main drafters of this standard. Ma Feng collar, Liu Junling, Cao Xuejun, Cai Dawei, Meng Hongwei, Zhao Liwei, Yao Juan, Tao Jing, Qu Jianguo, Sun Gang, Wu Guoshi.IntroductionProsthetics is a configuration service varies, highly targeted, complex professional work, be equipped with a dedicated production facilities and equipment, and And technical personnel in accordance with the requirements of scientific and rational procedures. Prosthetic configuration services involving health and safety of persons with disabilities, improper assembly, not only drop Low Wear comfortable, motor coordination and compensatory function, achieving the desired effect of rehabilitation, but may increase disability. Domestic institutions engaged in prosthetics due to differences in levels of development and size of the prosthetic configuration process at the reception, examination, prescription issue, configure Agreement, preparation, production, training, delivery, follow-up of the service requirements and other standards are not uniform. Moreover, because there is no corresponding standard Limb-fitting and standardize the quality of service constraints and evaluation mechanism, so that in the event of disputes or determine liability, not the interests of persons with disabilities Effective protection. Therefore, the standards are very necessary and urgent. The standards and specifications published on the prosthetics market and protect the rights of persons with disabilities will play a positive role. Prosthetic Configuration Service1 ScopeThis standard specifies the prosthetic configuration process Reception, check prescriptions issued configured agreement, save records and configuration protocols, assembly Preparation work, production, use of training, assembly quality inspection, delivery, logo, packaging requirements, transportation, storage, and other follow-up services. This standard applies to all types of institutions engaged in prosthetics.2 Normative referencesThe following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard. GB/T 191 Packaging - Pictorial signs GB/T 9174 General cargo transport packaging technology GB/T 13461 modular prosthetic leg GB/T 14191 prosthetics and orthotics term GB 14722 modular hip, thigh and knee prostheses GB/T 15721.1 Prosthetics and orthotics - Limb deficiencies - Part 1. congenital limb deficiencies described method GB/T 15721.2 Prosthetics and orthotics - Limb deficiencies - Part 2. Method of describing lower limb amputation stumps GB/T 15721.3 Prosthetics and orthotics - Limb deficiencies - Part 3. Method of describing upper limb amputation stumps GB/T 16432 Classification and terminology aids for disabled persons3 Terms and DefinitionsGB/T 14191, GB/T 15721.1, GB/T 15721.2, GB/T 15721.3, GB/T 16432 in established and following surgery Terms and definitions apply to this standard. 3.1 For the physically disabled persons to install, with prostheses, and final delivery process finished prosthesis. 3.2 According to the actual situation of the patient, a written document prosthetic configuration.4 General4.1 Process Prosthetic services should configure the operating process integrity and effective. 4.2 Liability Prostheses configured to implement the first diagnosis responsibility. If the first diagnosis of prosthetic production division changes, patients should be informed. Prosthetic configuration process reasonable division of responsibility to the people, the implementation of the signature system. 4.3 Security Respect patient privacy, there are likely to be exposed to the operation of patient privacy should be blocked to provide safe and effective protection measures.5 System Construction5.1 Management We shall establish an internal quality management system, regular assessment. 5.2 Resources 5.2.1 staff Prosthetics agency personnel should dress neatly, active service, sincere, patient, thoughtful. 5.2.2 facilities Prosthetics institutions should have to meet the production process configuration prosthetic devices, and the necessary accessibility. 5.2.3 Environment Prosthetics mechanism should have smooth reception work configuration prosthetic guarantee the quality, production, training, personal site, the environment should be Clean, quiet, comfortable. 5.3 Training Personnel should be regularly serviced limb-fitting body language, service skills training, service and other aspects of consciousness.6 prosthetic configuration General requirements6.1 General After determining prosthetic Configuration Protocol, under the patient actively cooperate in making prostheses in general should be completed within 30 days, the patient can be delivered. Special diseases Otherwise agreed calendar. 6.2 Reception 6.2.1 The reception staff should be warm to the patient asking difficult obstacles, the introduction of prosthetic products, encourage and inspire confidence in the rehabilitation of patients; Asked in detail about natural conditions and needs of patients, fill out the medical history, complete medical prostheses - Part 1 (see Appendix A). Medical prostheses - Part 1 includes at least the following information. --- Name, gender, age, nationality (or region), nationality, height, weight; --- Identification number and category; --- Information, mailing address; --- Home address, work units; --- Amputation reason, time, location; --- History (medical history, medical history, family history, past history of prosthetics). 6.2.2 If you have a medical history, medical records should have been invoked, and ask and record changes in circumstances. 6.2.3 truthfully publicize the unit to the patient, the product situation. 6.3 Check By the scope of the division responsible for the production of artificial limbs and stumps in patients with systemic conditions for questioning and examination, to understand dysfunction, and the degree of compensation can Force on disability given description. Inspection process, should make a detailed record of the inspection program, including patient information, fill out the medical prostheses - Part 2 (see Appendix B And Appendix C. Wherein the configuration of the lower limb prosthesis size measured according to GB 14722, GB/T 13461 measurements table). Medical prostheses - Part 2 includes at least the following information. --- Systemic conditions, including mental state, the state of consciousness; --- Living and working environment, if there are special requirements; --- Residual limb conditions, such as range of motion, bone, muscle, skin, nerves and size and so on. 6.4 issued prescriptions prostheses According to amputation reason, loss of function, the psychological condition, medical history, activity, living and working environment, and to consult patients and their families After the comments, to the greatest extent compensate for the missing function of patients for the purpose of determining the type of prostheses, components, materials and the necessary rehabilitation plan, the first Diagnosis of prosthetic production division issued a prosthetic prescription. Patients or their families to sign an agreement. The main components should be in line with national standards for inspection within the validity period of qualified products. Medical prostheses prosthetic prescription is part of the third (see Appendix D). Content prosthetic prescription should include at least the following information. --- Patient name, sex, age, body parts missing; --- Prosthetic type. Prostheses name; --- Parts. the parts of the constitution, the main components of the model and manufacturer; --- Materials. The materials used in the name of the material. 6.5 Configuration Protocol signed prostheses After issuing prescriptions prostheses, prosthetic configuration protocol should be signed, see Appendix E. Content prosthetic configuration protocol should include at least the following information. --- Prosthetic type. Prostheses name; --- Parts. the composition and type of the various components; --- Material. Name of the materials used; --- Costs, including the price of prosthetics; ---payment method; --- Delivery time; --- Dispute resolution. 6.6 prostheses and prosthetic records Save Configuration Protocol Medical prostheses and prosthetic configuration protocol shall be kept for at least 15 years. 6.7 Preparations before prosthetics 6.7.1 prosthetics makers should first read the prescription, according to the procedure to work. 6.7.2 describe in detail the expected conditions and precautions compensation to the patient. 6.7.3 according to the patient stump, the stump to develop the necessary training and rehabilitation programs. 6.7.4 to determine whether a temporary prosthetic assembly. 6.8 Production prosthetics Measurement, take type, repairing, receiving chamber forming of lines should be the relevant technical specifications for the operation. 6.9 prostheses using the training Should be under the guidance of the professionals, with the necessary rehabilitation equipment and appliances, were worn prosthetic training, functional training, as well as daily prosthetic clear Jie conservation. 6.10 prosthetics QA Prosthetics in the handover process, staff should carefully check, signature, progressively responsible. 6.10.1 by professionals, should be carried out to try to check the following items. --- In line with the prescription; --- Main parts and materials meet the protocol requirements; --- Compensatory function well. 6.10.2 After assembly is completed, the patient should try, try. Press 6.9.4 Check suitability. 6.10.3 according to patient feedback, make the necessary adjustments. 6.10.4 complete prosthetic main part preliminary assembly, and patient specimens, the initial adaptation assessment. Early 6.10.4.1 suitability checks include. --- Worn correctly; --- Adaptation of the stump and the receiving chamber; --- Check on line to meet the requirements; ---length; --- The joint range of motion; --- Check the worn prosthetic limb after; --- Prosthetic suspension. Early 6.10.4.2 limb adaptation checks addition to these requirements should also include control functionality. Early 6.10.4.3 lower limbs adaptation checks addition to these requirements shall include. --- Accept wire lumen and lower limb member; --- Receiving chamber edge height; --- Check the sitting position; --- Dynamic walking inspection. After all finished prosthetic 6.10.5, including packaging, before the formal delivery of patients to be adapted final evaluation. Prosthetics final inspection together After Georgia, delivered the official patient use. 6.10.5.1 upper extremity end of suitability tests include. --- Prosthetic production meets the prescription requirement; --- Appearance is similar to healthy side; --- Prosthetic safety; --- Patients with ease. 6.10.5.2 lower extremity end of suitability tests include. --- Prosthetic production meets the prescription requirement; --- Appearance is similar to healthy side; --- Receiving chamber meets the design requirements; --- Prosthetic security. 6.10.6 prosthetic production division signed acceptance. 6.10.7 guide patients and their families the right to use prosthetic methods and precautions, including stump care.7 prosthetic delivery7.1 checked qualified prostheses after patients confirmed, for delivery procedures, and record keeping. 7.2 Eligible syndrome patients, the warranty card and instructions. 7.2.1 certificate Certificate includes at least the following information. a) Name of the assembly; b) the type of prostheses; c) the patient's name; d) patient medical record number; e) date of completion of the assembly. 7.2.2 Warranty Card Warranty card include at least the following information. --- Name of the patient; --- Patient medical record number; --- Prosthetic type; --- Assembly completion date; --- Warranty; --- Warranty period; --- Prosthetic care and maintenance considerations; --- Maintenance records, including the maintenance of content and time; --- Customer Information, including address, phone, fax, mail and so on. See Appendix F. 7.2.3 Specification Product specification include at least the following information. ---Instructions; ---Precautions; --- Receiving chamber maintenance; --- Maintenance parts; --- Decoration sock maintenance. See Appendix G. 7.3 If the patient to ask questions or other requirements, and should be responded to within 48h. 8 signs, packaging, transportation, storage 8.1 mark Shall be affixed to the outside of the prosthetic socket marked with a label assembly institution name. 8.2 Packaging, transport 8.2.1 If you need to send, should be installed in a dust bag, there are applications that require dark dark bags. It should also be loaded into the packaging bag warranty card, together Grid certificate and product brochures. 8.2.2 Transport crates should be consistent with the provisions of GB/T 9174, the Packaging - Pictorial signs should be consistent GB/T 191 requirements. 8.3 Storage Before delivery patients should complete package, stored in ventilated, dry coffers, and substance isolated from flammable and corrosive chemicals and the like. 9 Follow-up 9.1 follow-up record table According to the agreement and the actual situation of the patient, the assembly should be regular follow-up mechanism, and make a record (see Appendix H) in the follow-up record table. Follow-up record sheet should include at least the following information. --- Prosthetic usage; --- Stumps condition; --- Individual requests and recommendations; --- Recommend treatment advice. 9.2 General requirements for follow-up Regular follow-up may take the phone, letter, e-mail, visits and other forms. If prosthetics mechanism changes, shall promptly inform the patient. If the product components in need of replacement or repair, shall promptly inform the patient. Follow-up interval, as the case may be, should generally 3 months, 6 months or 1 year.Appendix A(Normative) Prosthetic configuration medical home Name. Sex. Age. the age of the patient medical record number. Country (Region). Nationality. Height. cm Weight. kg Type of ID. ID □ □ □ Passport officer (soldier) certificate □ Other. ID Number. Phone. Address. Zip Code. Home Address. Employer. Amputation Cause. Amputation time. date amputation. History (medical history, medical history, family history, past history of prosthetics). Other situations should be noted. Admissions Signature. visit Date. The dateAppendix B(Normative) Prosthetic Configuration Checklist Name. Patient medical record number. Residual side. Left □ □ □ plane and right sides of amputation. long stump cm (healthy limb%) Amputation Date. The date amputation Cause. after treatment. The Does anybody care. Yes □ No □ This is the first time a prosthesis, the first installation of Time. The date 1. Health conditions (heart blood diseases, drug dependence cycle, other diseases) 1.1 Cardiovascular Disease. □ No □ Yes. 1.2 Other physical diseases. □ No □ Yes. 1.3 Other diseases. □ No □ Yes. 1.4 drug use. □ No □ Yes. 1.5 is normal motor coordination. □ Yes □ No. 1.6 standing, sitting balance is normal. □ Yes □ No. 2. Amputee living and working environment 2.1 residential road. □ flat hill □ □ □ uneven steps . 22 everyday life. □ self □ Care 2.3 Occupation. 2.4 Working and living in the main position. □ □ Station □ sit walk 2.5 Working and living in the main mode of transport. □ foot □ bike □ public transport □ car □ Wheelchair □ Other. 3. Stump clinical examination 3.1 Control limb muscle strength. abduction within close stretch flexion (Strength Rating. 0,1,2,3,4,5) 3.2 limb joint range of motion Flexion/Neutral/extension. Active Passive // // Adduction/neutral/Outreach. active passive // // Pronation/neutral/external rotation. active passive // // 3.3 abduction or flexion contracture deformity. □ No □ Yes. 3.4 Can stump bearing. □ No □ can stump load capacity. □ low □ medium □ high 3.5 subcutaneous tissue. □ soft □ in (normal) □ Hard □ small □ medium □ more 3.6 Skin scar adhesions. □ No □ Yes. color. □ No □ Yes. 3.7 skin sensitive parts. □ No □ Yes. allergy. □ No □ Yes. 3.8 phantom limb sensation. □ No □ Yes phantom limb pain. □ No □ Yes. 3.9 compared with the contralateral limb temperature. □ same □ low □ high 3.10 bone protrusion end. □ No □ Yes. 3.11 Have stump edema. □ No □ Yes. 3.12 stumps other questions. Remarks. Prosthetic production division Signature. Record time. dateAppendix C(Normative) Prosthetic size measurement configuration record Name. Patient medical record number. Figure C. A prosthetic arm configuration Measure Prosthetic production division Signature. Measuring time. date Name. Patient medical record number. Figure C. 2 forearm prostheses configured size measurement Prosthetic production division Signature. Measuring time. date Name. Patient medical record number. Figure C. 3 shoulder disarticulation prostheses configured size measurement Prosthetic production division Signature. Measuring time. date Name.......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB 22457-2008_English be delivered?Answer: Upon your order, we will start to translate GB 22457-2008_English as soon as possible, and keep you informed of the progress. The lead time is typically 3 ~ 5 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB 22457-2008_English with my colleagues?Answer: Yes. The purchased PDF of GB 22457-2008_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay. |
