January 26, 2022
Changes in regulation (Nov - Dec 2021)
Updates in standards for the period November - December 2021:
| Related to | Earlier | In 2021 | Main changes |
| Updates dated 01 November till 31st of December 2021 | |||
| Standards for medical devices | Introduced for the first time | GOST R 59426-2021 | 1. This standard specifies the requirements for the friction units of total knee joint endoprostheses (hereinafter referred to as the product) used as surgical implants in bone surgery. |
| Standards for medical devices | GOST R ISO 8548-2-2011 | GOST R ISO 8548-2-2021 | 1. It has been harmonized with the international standard ISO 8548-2:2020
2. This standard specifies methods for describing the lower limb amputation stumps and lists the measurements required for prosthetics 3. A description of the stump has been added, the rules for measuring the stump have been described in more detail |
| Standards for medical devices | GOST R 56137-2014 | GOST R 56137-2021 | 1. This standard specifies the types, methods and procedures for quality control of external prostheses and orthoses (orthopaedic devices and removable joint-immobilizers) of the upper and lower limbs with individual manufacturing parameters
2. The lists of prostheses subject to quality control have been updated. References to regulatory acts have been updated |
| Standards for medical devices | GOST R 52114-2009 | GOST R 52114-2021 | 1. The scope has been adjusted: This standard applies to units of mechanical prostheses of the upper limbs placed in a specified position by the efforts of human muscles and (or) with the help of an external force and belong to subclass 06 18 according to GOST R ISO 9999
2. Technical requirements have been adjusted (updated to new standards) |
| Standards for medical devices | GOST R 53346-2009 | GOST R 53346-2021 | 1. This standard applies to metal units of lower-limb orthoses (hereinafter referred to as the units) intended for users weighing between 15 and 125 kg.
2. Reliability requirements have been updated 3. Requirements for knee units have been adjusted 4. References to regulatory acts have been updated |
| Standards for medical devices | GOST R 53869-2010 | GOST R 53869-2021 | 1. The scope has been adjusted: This standard applies to customized lower limb prostheses (hereinafter referred to as the prostheses) intended for users weighing between 15 and 125 kg at any level of amputation and congenital underdevelopment of the lower limbs by type of stump or longitudinal form of underdevelopment with marked shortening of the segments.
2. Material requirements have been updated 3. Regulatory acts have been updated |
| Standards for medical devices | GOST R 57771-2017 | GOST R 57771-2021 | 1. The scope has been updated: This standard applies to electronic units of upper and lower limb prostheses (hereinafter referred to as the units) and specifies the technical requirements for the units.
This standard does not apply to units for children and special prostheses (sports, working and training prostheses), as well as to customized units 2. Packaging requirements have been added 3. Regulatory acts have been updated |
| Standards for medical devices | GOST R 53871-2010 | GOST R 53871-2021 | 1. This standard applies to lower limb prostheses and establishes the following methods for evaluating the rehabilitation efficiency of lower limb prosthetics (hereinafter referred to as the evaluation methods): clinical and biomechanical.
2. Methods for evaluating the clinical data have been updated 3. References to regulatory acts have been updated |
| Standards for medical devices | Introduced for the first time | GOST R 59527-2021 | 1. This standard applies to thoracic orthopaedic bandages (hereinafter referred to as bandages, products) for children, adolescents and adults, designed for the support and correct fusion of bones after fractures of the chest and ribs, after surgery, including heart surgery, with keel-shaped, funnel-shaped chest deformities, the prevention of injuries and deformities, in the rehabilitation process. |
| Standards for medical devices | Introduced for the first time | GOST R ISO 29783-2-2021 | 1. This standard provides a vocabulary for describing walking with prostheses. |
| Standards for medical devices | Introduced for the first time | GOST R 59449-2021 | 1. This standard applies to urinary stoma care products, devices for urinary incontinence in men and urinary retention and specifies their composition, purpose and characteristics, basic requirements and test methods. The terms established by this standard are recommended for use in documentation and literature in the field of aids for people with disabilities that are within the scope of standardization works and/or use the results of these works, of all types. |
| Standards for medical devices | Introduced for the first time | GOST R 59450-2021 | 1. This standard applies to absorbent urological underpants for women and men suffering from a slightly impaired excretion function — a mild urinary incontinence (up to 400 ml within 8 hours) and designed to absorb and hold urine, and also establishes requirements for their quality. |
| Standards for medical devices | Introduced for the first time | GOST R 59524-2021/ISO/IEEE 11073-10408:2010 | 1. This standard specifies a normative definition for communication between personal thermometer telemedicine devices and computing devices (e.g., cellular phones, personal computers, home health monitors and set-top boxes) in a manner that provides plug-and-play compatibility. It uses the relevant components of existing standards, including terminology, information models, application profile standards and transport standards of the ISO/IEEE 11073 set of standards. |
