New national standards for medical and healthcare professionals approved
1. GOST R 58484-2019 “Surgical inactive implants. Hyaluronic acid implants. Standard guidance for determining the characteristics of hyaluronic acid as the basis for medical devices” was approved by order of Rosstandart of August 8, 2019 N 481-st.
The standard applies to hyaluronic acid intended for use in biomedical and / or pharmaceutical purposes, including in tissue engineering. The standard is intended to determine the methods and types of research for hyaluronic acid that are necessary for its proper characterization and evaluation during a specific application, as well as to establish approaches to determine the purity of hyaluronic acid, including its main characteristics.
GOST R 58484-2019 is put into effect on the territory RF from May 1, 2020.
2. GOST R ISO 5838-2-2019 “Implants for surgery. Rods, knitting needles and wire for skeletal traction. Part 2. Skeleton pins Steinmann. Dimensions” approved by the order of Rosstandart from August 8, 2019 N 482-Art.
The standard establishes the dimensions of the Steinmann skeletal pins. Requirements for materials and mechanical properties are given in ISO 5838-1.
GOST R ISO 5838-2-2019 will be enforced in the Russian Federation on May 1, 2020.
3. GOST R ISO 5838-3-2019 “Implants for surgery. Rods, knitting needles and wire for skeletal traction. Part 3. Kirschner spokes for skeletal traction” was approved by order of Rosstandart of August 8, 2019 N 483-st.
The standard establishes the technical characteristics of Kirchner spokes for skeletal traction. Requirements for materials and mechanical properties are given in ISO 5838-1.
GOST R ISO 5838-3-2019 will be enforced in the Russian Federation on May 1, 2020.
4. GOST R ISO 7206-12-2019 “Implants for surgery. Partial and total hip arthroplasty. Part 12. Test method for deformation for acetabular cups” was approved by order of Rosstandart of August 8, 2019 N 484-st.
The standard establishes a test method for determining the short-term deformation of the press fit of the acetabular component with a complete replacement of the hip joint in specific laboratory conditions, and also describes the testing conditions in order to take into account important parameters that affect the components and the installation of the test sample. In addition, the standard defines test parameters for acetabular components. This method is intended for evaluative comparison of various structures and materials used for the components of the acetabulum during total replacement of the hip joint, tested under similar conditions. The in vivo loading of acetabular components will be different from the load defined in this test method. The results cannot be used to directly predict in vivo functioning. The standard does not cover test methods for the test sample.
GOST R ISO 7206-12-2019 will be enforced in the Russian Federation on May 1, 2020.
5. GOST R 51633-2019 “Rehabilitation devices and appliances used by persons with disabilities in residential premises. General technical requirements” was approved by order of the Federal Standard of August 6, 2019 N 446-Art.
The standard applies to rehabilitation devices and devices intended for independent use by persons with disabilities who have a violation of the static-dynamic function in residential premises and belonging to the groups of technical rehabilitation equipment in accordance with GOST R ISO 9999. Requirements for ensuring the rehabilitation effect and safety are mandatory.
GOST R 51633-2019 entered into force on the territory of the Russian Federation from March 1, 2020.