Health Care Standards Overview

ASTM Standards for Healthcare Services, Products, and Technology

Every day around the globe, ASTM International standards make a vital contribution in the healthcare field. They advance human health by improving care delivery, supporting medical research and drug development, enhancing product manufacturing, and much more. Developed by top healthcare practitioners, engineering leaders, and other technical experts, ASTM International standards drive the science and innovation that lead to longer, fuller lives.

With more than 950 professionals from 30+ countries, the committee on medical and surgical materials and devices (F04) oversees more than 300 standards that help bring life-saving breakthroughs to patients worldwide.

Today, the committee on medical and surgical materials and devices (F04) addresses standards for instruments, orthopaedic devices, implant systems, and more:

  • Biocompatibility and magnetic resonance imaging
  • Osteosynthesis and spinal devices
  • Cardiology, neurology, audiology, gastroenterology, and plastic surgery
  • Computer-assisted orthpaedic surgical systems
  • Ceramics, metals, and polymers
  • Cell signaling
  • Tissue engineered medical products

Advancing TEMPs

Tissue engineered medical products (TEMPs) use biological components alone or with synthetic components to regenerate human tissue. To support continued progress in this field, TEMPs groups focus on classification and terminology, biomaterials and biomolecules, cells and tissue engineered constructs, assessment, adventitious agent safety, and cell signaling.

Standards in this cutting-edge area include the:

  • Guide for the characterization and testing of biomaterial scaffolds used in TEMPs (F2150), including metallic, ceramic, polymeric, natural, and composite materials; and
  • Guide for micro-computed tomography of tissue engineered scaffolds (F3259).

Promoting MR Safety

Advances in magnetic resonance (MR) imaging technology have grown dramatically since the 1980s. MR scanners help physicians study nerves, muscles, ligaments, bones, and other tissues, helping to diagnose and treat injuries and disease.

In the magnetic resonance (MR) environment, potential hazards exist for patients, technologists and radiographers, and other medical professionals. Scanner magnets and pulses can damage implants such as pacemakers, and projectile accidents may also occur. The practice for marking medical devices and other items for safety in the magnetic resonance (MR) environment (F2503) helps ensure patient safety and reduce technologist confusion. Recognized in U.S. Food and Drug Administration guidance, F2503 provides a uniform marking system that indicates the conditions where a device may be safely used. It provides the labeling terms and associated visual icons to help prevent injuries from potentially hazardous items in the MR environment. Related standards such as tests for passive medical device heating (F2182), magnetically induced displacement force on medical implants (F2052), and MR image artifacts from passive implants (F2119) also support safety. evaluation of MR image artifacts from passive implants (F2119) also support safety.

Musculoskeletal Implant Labeling

One significant medical device standard provides a consistent labeling approach that also supports implant selection. The guide for presentation of end user labeling information for musculoskeletal implants (F2943) covers a universal label format, content, and information placement.

3D Printing Standards Transform Manufacturing

The committee on additive manufacturing technologies (F42) is making a powerful impact on the medical industry.

3D printing facilitates products and parts by applying material or powder in very thin layers in the production process. These processes improve the design, testing, and manufacturing of many patient medical devices such as hearing aids, dental crowns, surgical implants, and surgical instruments.

Additive manufacturing (AM) standards support innovation in plastic and metal materials used for medical devices. Among these are standards for titanium (F2924 and F3001) and cobalt chrome (F3213) for powder bed fusion for critical components such as those used in aerospace and medical applications.

The AM committee is developing several standards that address medical applications as well as include them. Proposed standards, among others, cover data formats, process validation, powder reuse, and qualifying machine operators who work on metallic parts production.

Ensuring Safety in Pharmaceutical and Medical Product Packaging

The committee on primary barrier packaging (F02) develops medical packaging standards that help meet the needs of regulators and manufacturers around the world. Such packaging helps maintain device sterility and protects the contents.

Many standards from the committee support critical medical products. For example:

  • The classification of child-resistant packages (D3475) defines the motions, skills, or tools required for a particular type of child-resistant package,
  • The specification for user-applied drug labels for anesthesiology (D4774) addresses label size, color and pattern, and type used on labels to better identify the drug content.

Two additional important standards support medical packaging integrity:

  • The test method on seal strength of flexible barrier materials (F88) covers measurement techniques that provide process validation, control, and capability; and
  • The test for detecting gross leaks in packaging by internal pressurization (F2096), the “bubble test,” is used to inspect medical packaging for any bubble streams caused by packaging/sterile barrier system defects.

The committee continues to develop standards that support medical packaging quality, including a test to help identify packaging leaks (F3287), a guide to validate medical packaging tests (F3263), and a test for water vapor transmission through plastic film and sheeting (F3299).

PPE Standards and Global PPE Forum

ASTM International has launched a new global cooperation forum to address challenges facing personal protective equipment and accelerating related standards development: a forum that unifies PPE standardization work and leverages the collective capabilities of the PPE industry.

A white paper, “Global Collaboration to Advance Personal Protection (PPE) Safety, Quality, and Innovation,” has been published; it explains the current landscape in PPE and ASTM’s work accomplished and underway in this area as well as its plans for the cooperative forum. The forum will provide a hub for collaborative activities and interorganizational communication.

Already active in the area of PPE, the committee on personal protective clothing and equipment (F23) oversees standards for masks and gowns for consumer and healthcare use. The committee has developed a standard (F3502) that applies to barrier face coverings for the general public and workers; it includes requirements that cover design and construction, particle filtration efficiency levels, sizing and fit testing criteria, labeling instructions, and guidance on cleaning and recommended periods of use.

Additional mask standards include the foundational specification for performance of materials used in medical face masks (F2100) as well as tests for penetration resistance (F2299, F1862) and filtration efficiency (F2101). Medical gowns standards include the specification for surgical gowns intended for use in healthcare facilities (F2407) and tests that determine bloodborne pathogen resistance (F1671) and thermal and evaporative resistance of clothing materials (F1868). The committee on textiles (D13) is responsible for gown-related standards as well.

Nanotechnology Standards Support Cancer Research

The battle against cancer is getting a boost from standards developed by the committee on nanotechnology (E56). The committee supports cutting-edge research efforts that could pave the way for commercially available nanoscale cancer drugs.

Standards in this area include:

  • The test for analyzing the hemolytic properties of nanoparticles (E2524), a method to examine the destruction of red blood cells (hemolysis), which can lead to anemia and other issues;
  • The test to evaluate the effect of nanoparticulate materials on the formation of granulocyte-macrophage colonies (E2525);
  • The test to evaluate the cytotoxicity of nanoparticulate materials by examining effects on kidney and cancerous liver cells (E2526); and
  • The practice for performing cryo-transmission electron microscopy of liposomes (E3143), which supports this type of nanomaterial-based drug product.

Drug developers; scientists in the pharmaceutical, cancer research, and nanotechnology fields; regulatory agencies; and groups evaluating the health and safety risks associated with nanoscale materials all have use for the standards.

Medical Device Cleaning and Cleanliness

The medical and surgical materials and devices committee continues to respond to current standards development needs. Among them, the increased interest in reusable medical devices has led to tackling standards for device cleaning and cleanliness.

The subcommittee on material test methods (F04.15) has completed guides for:

  • Selecting (F3208), applying (F3293), and extracting (F3321) test soils for validation of cleaning methods for reusable medical devices;
  • Using a force tester to evaluate a brush part designed to clean the internal channel (F3275) and the external surface (F3276) of a medical device; and
  • Designing reusable medical devices for cleanability (F3357).

The committee is also advancing quality and safety with standards for medical textile stiffness (F3260), absorbable metal degradation testing (F3268), spinal implant inspection (F3292), and for ion release evaluation of implants (F3306).

Standards Support Sterile Medical Products

The committee on radiation processing (E61) oversees more than 30 standards, including practices and guides for using radiation processing on medical products, pharmaceuticals, and other goods. Radiation processing involves controlled application of gamma rays, electrons, or X-rays to kill any microorganisms that might be present.

Standards in this area include:

  • The practice for calibration of routine dosimetry systems for radiation processing (ISO/ASTM 51261), including measurement traceability and estimating uncertainty;
  • The practice for dosimetry in radiation processing (ISO/ ASTM 52628), which describes requirements that apply when making measurements according to E61 dosimetry standards; and
  • The guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing (ISO/ASTM 52701), which covers what might affect performance.

Building a New Road Map for Pharmaceutical Manufacturing

When it comes to pharmaceutical manufacturing, one committee focuses on quality and efficiency.

The committee on manufacture of pharmaceutical and biopharmaceutical products (E55) grew from an expansion of Process Analytical Technology (PAT), developed by the U.S. Food and Drug Administration to improve drug manufacturing processes and help

ensure more reliable consumer products. This built the foundation for the committee, which aims to further the PAT framework in the industry. Standards in this area include PAT terminology (E2363), pharmaceutical process design (E2474), and PAT instrument sampling (E3177).

Beyond PAT, the committee has developed standards for the design and verification of manufacturing systems and equipment (E2500), continuous quality verification (E2537), real-time release testing (E2656), testing of uniformity of dosage units (E2810), and qualification of basket and paddle apparatus (E2503). More recent work expands into science and risk-based cleaning processes (E3106), particle analysis (E3060), and single use system design and verification (E3051).

The committee also focuses on biopharmaceutical product manufacturing, including standards for single-use systems and raw materials pharmaceutical development and manufacturing, notably biotechnology. Among the standards underway is a practice for testing system integrity.

As the industry continues to evolve, so does the work of E55. In response to growing challenges and new processes, the committee has formed subcommittees to explore standards for pharmaceutical manufacturing applications and guidance using lyophilization, and for microbial and sterility assurance for pharmaceutical and biopharmaceutical products.

Supporting the Entire Healthcare System

More ASTM committees are involved in standards that enhances healthcare products and services worldwide.

  • The committee on rubber and rubber-like materials (D11) is responsible for standards that support the quality, performance, and safety of medical gloves. These include the specification for rubber surgical gloves (D3577), which details several performance tests; methods to detect holes in medical gloves (D5151) and residual powder (D6124); a practice for assessing the resistance of medical gloves to permeation by chemotherapy drugs (D6978); and a practice for determining medical glove expiration dates (D7160).
  • The committee on emergency medical services (F30) focuses on standards related to EMS equipment; emergency medical technicians/first responder training; organization and management; and communications. The standards include the guide for structures and responsibilities of EMS system organizations (F1086) and the practice for training the emergency medical technician (basic) (F1031).

The ASTM technical committees highlighted in this piece include:

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