ASTM F748-25材料和器械生物试验方法选择的标准实施规程

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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the

Development of International Standards,Guides and Recommendations ssued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.

Designation:F748-25

INTERNATIONAL

Standard Practice for

Selecting Biological Test Methods for Materials and

Devices

This standard is issued under the fixed designation F748;the number immediately following the designation indicates the year of original

adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.A superscript

epsilon(e)indicates an editorial change since the last revision or reapproval.

1.Scope

1.1 This practice describes biological test methods(as listed

in 2.1)which may be used in support of a biological evaluation

of materials and medical devices according to end-use appli-

cations.Biological evaluation is a component of a broader

safety evaluation and is conducted within an ISO 14971 risk

management framework.ISO 10993-1 sets out the general

principles and requirements for such an evaluation.A biologi-

cal evaluation conducted according to ISO 10993-1 requires a

consideration of the composition of the medical device and the

review of pre-existing information pertinent to biological risks.

In many cases this pre-existing information will be sufficient to

establish safety without a need for additional testing.Only

where existing information is insufficient it may be necessary

to conduct further testing (see ISO 10993-1).The purpose of

this document is to provide guidance on available and appli-

cable test methods to support such testing activities if they are

required.

1.2 The reader is cautioned that the area of biocompatibility

testing is a rapidly evolving field,and improved methods are

becoming available continuously,so this practice is a guide-

line.A thorough knowledge of current techniques and research

is critical to a complete evaluation of new materials and

medical devices.

1.3 Biological evaluation of materials and medical devices

for human application is discussed.Tests include those per-

formed on materials,final finished medical devices,and

extracts.The current state of the art is included for all test

procedures described.

1.4 The biocompatibility of materials used in single or

multicomponent medical devices for human use depends to a

large degree on the particular nature and duration of tissue

contact during intended use.It is not possible to specify a set

of test methods which will be necessary and sufficient to

establish biocompatibility for all materials and applications.

¹This practice is under the jurisdiction of ASTM Committee F04 on Medical and

Surgical Materials and Devices and is the direct responsibility of Subcommittee

F04.16 on Biocompatibility Test Methods.

Current edition approved Feb15,2025.Published February 2025.Originally

approved in 1982.Last previous edition approved in 2016 as F748-16.DOI:

10.1520/F0748-25.

Because biological reactions caused by a material or a medical

device can have different implications or raise different safety

concerns depending on the type and duration of tissue contact

of the medical device,each application must be evaluated for

biocompatibility and any associated testing on its own merit.

1.5 The evaluation of tissue-engineered medical products

(TEMPs)may,in some cases,involve different or additional

testing beyond that conducted on non-TEMPs-based materials

and medical devices.Where appropriate,these differences are

discussed in this practice and additional tests described.For

additional information,see reference standards published un-

der the jurisdiction of the applicable TEMPs Subcommittees of

F04.

1.6 The ethical use of research animals places the obligation

on the individual investigator to determine the most efficient

methods for performing the necessary testing without undue

use of animals.Where adequate prior data exists to substantiate

certain types of safety information,these guidelines should not

be interpreted to mean that testing should be unnecessarily

repeated.Refer to ISO 10993-2 for additional information.

1.7 This standard does not purport to address all of the

safety concerns,if any,associated with its use.It is the

responsibility of the user of this standard to establish appro-

priate safety,health,and environmental practices and deter-

mine the applicability of regulatory limitations prior to use.

1.8 This international standard was developed in accor-

dance with internationally recognized principles on standard-

ization established in the Decision on Principles for the

Development of International Standards,Guides and Recom-

mendations issued by the World Trade Organization Technical

Barriers to Trade (TBT)Committee.

2.Referenced Documents

2.1 ASTM Standards:²

F619 Practice for Extraction of Materials Used in Medical

Devices

²For referenced ASTM standards,visit the ASTM website,www.astm.org,or

contact ASTM Customer Service at www.astm.org/contact.For Annual Book of

ASTM Standards volume information,refer to the standard's Document Summary

page on the ASTM website.

F748-25

F719 Practice for Testing Materials in Rabbits for Primary

Skin Irritation

F720 Test Method for Testing Guinea Pigs for Contact

Allergens:Guinea Pig Maximization Test

F749 Practice for Evaluating Material Extracts by Intracuta-

neous Injection in the Rabbit

F750 Practice for Evaluating Acute Systemic Toxicity of

Material Extracts by Systemic Injection in the Mouse

F756 Practice for Assessment of Hemolytic Properties of

Materials

F763 Practice for Short-Term Intramuscular Screening of

Implantable Medical Device Materials

F813 Practice for Direct Contact Cell Culture Evaluation of

Materials for Medical Devices

F895 Test Method for Agar Diffusion CellCulture Screening

for Cytotoxicity

F981 Practice for Assessment of Muscle and Bone Tissue

Responses to Long-Term Implantable Materials Used in

Medical Devices

F1408 Practice for Subcutaneous Screening Test for Implant

Materials

F1439 Guide for Performance of Lifetime Bioassay for the

Tumorigenic Potential of Implant Materials

F1841 Practice for Assessment of Hemolysis in Continuous

Flow Blood Pumps

F1877 Practice for Characterization of Particles

F1903 Practice for Testing for Cellular Responses to Par-

ticles in vitro

F1904 Guide for Testing the Biological Responses to Medi-

cal Device Particulate Debris and Degradation Products in

vivo

F1983 Practice for Assessment of Selected Tissue Effects of

Absorbable Biomaterials for Implant Applications

F2147 Practice for Guinea Pig:Split Adjuvant and Closed

Patch Testing for Contact Allergens

F2148 Practice for Evaluation of Delayed Contact Hyper-

sensitivity Using the Murine Local Lymph Node Assay

(LLNA)

F2382 Test Method for Assessment of Circulating Blood-

Contacting Medical Device Materials on Partial Throm-

boplastin Time(PTT)

F2888 Practice for Platelet Leukocyte Count—An In-Vitro

Measure for Hemocompatibility Assessment of Cardio-

vascular Materials

F2901 Guide for Selecting Tests to Evaluate Potential Neu-

rotoxicity of Medical Devices

2.2 Other Referenced Documents:

ISO 7405 Evaluation of biocompatibility of medical devices

used in dentistry³

ISO 10993-1 Biological evaluation of medical devices—Part

1:Evaluation and testing within a risk management

process³

ISO 10993-2 Biological evaluation of medical devices—Part

2:Animal welfare requirements³

ISO 10993-3 Biological evaluation of medical devices—Part

³Available from American National Standards Insitute(ANSD),25W.43rd St.,

4th Floor,New York,NY 10036,http://www.ansi.org.

3:Tests for genotoxicity,carcinogenicity and reproductive

toxicity³

ISO 10993-4 Biological evaluation of medical devices—Part

4:Selection of tests for interactions with blood³

ISO 10993-5 Biological evaluation of medical devices—Part

5:Tests for in vitro cytotoxicity³

ISO 10993-6 Biological evaluation of medical devices—Part

6:Tests for local effects after implantation³

ISO 10993-10 Biological evaluation of medical devices—

Part 10:Tests for skin sensitization³

ISO 10993-11 Biological evaluation of medical devices—

Part 11:Tests for systemic toxicity³

ISO 10993-12 Biological evaluation of medical devices—

Part 12:Sample preparation and reference materials³

ISO 10993-20 Biological evaluation of medical devices—

Part 20:Principles and methods for immunotoxicology

testing of medical devices³

ISO 10993-22 Biological evaluation of medical devices—

Part 22:Guidance on nanomaterials³

ISO 10993-23 Biological evaluation of medical devices—

Part 23:Tests for irritation³

ISO 14971 Medical devices—Application of risk manage-

ment to medical devices³

ISO 18562-1 Biocompatibility evaluation of breathing gas

pathways in healthcare applications—Part 1:Evaluation

and testing within a risk management process³

ISO 22442 Medical devices utilizing animal tissues and their

derivatives ³

ISO/TS 37137-1 Biological evaluation of absorbable medi-

cal devices—Part 1:General requirements³

ANSI/AAMI ST72 Bacterial endotoxins—Test methods,

routine monitoring,and alternatives to batch testing³

USP<85> Bacterial Endotoxins Test⁴

USP<151> Pyrogen Test⁴

USP<161> Medical Devices—Bacterial Endotoxin and Py-

rogen Tests⁴

FDA Use of International Standard ISO 10993-1,“Biologi-

cal evaluation of medical devices-Part 1:Evaluation and

testing within a risk management process”-Guidance for

Industry and Food and Drug Administration Staff(Sep-

tember 8,2023)⁵

FDA Immunotoxicity Testing Guidance⁶

FDA Guidance for Industry Preparation of IDEs and INDs

for Products Intended to Repair or Replace Knee Carti-

lage⁷

FDA Knee Joint Patellofemorotibial and Femorotibial

Metal/Polymer Porous-Coated Uncemented Prostheses-

Class II Special Controls Guidance Document for Industry

and FDA⁸

4Available from U.S.Pharmacopeial Convention(USP),12601 Twinbrook

Pkwy.,Rockvile,MD 20852-1790,http://www.usp.org.

5https://www.fda.gov/media/142959/download

⁶https://www.fda.gov/regulatory-information/search-fda-guidance-documents/

immunotoxicity-testing-guidance

7https://www.fda.gov/media/82562/download

8https://www.fda.gov/medical-devices/guidance-documents-medical-devices-

and-radiation-emitting-products/knee-joint-patellofemorotibial-and-femorotibial-

metalpolymer-porous-coated-uncemented-prostheses

F748-25

3.Terminology

3.1 Definitions:

3.1.1 endpoint—the term refers to certain parameters mea-

sured as primary or surrogate outcomes for biological or toxic

responses under assessment.

3.1.2 novel material—the term refers to a material that has

not been previously used in any legally marketed device.9

4.Significance and Use

4.1 The objective of this practice is to provide information

to consider when selecting and conducting biological testing,

when deemed necessary.

4.2 A matrix listing the biological endpoints relevant to a

biocompatibility evaluation of materials,medical devices,and

their applications is included in Table 1.The expected nature of

tissue contact and duration of use of a medical device is also

included.The position of row and column intersection is

marked to indicate the types of biological tests that should be

considered for a material or medical device for the specific

application,when testing is warranted.

5.Classification of Materials and Devices by End-Use

Applications

5.1 General:

5.1.1 Classification should focus on device materials that

will have direct or indirect tissue contact.Manufacturing

processes that can potentially alter the chemical,physical,or

biological characteristics of a raw material should be consid-

ered.It is preferable to obtain material test articles directly

from the final medical device to ensure that the manufacturing

processes,including cleaning,packaging,sterilization,and any

other procedures used in production and preparation of the

medical device are evaluated.Consideration should be given to

reprocessed medical devices and the effects reprocessing may

have on the biocompatibility profile.Novel materials may

require specialized testing to ensure they do not impart

unacceptable risks if not appropriately characterized.

5.1.2 In addition to considering the duration and type of

tissue contact of a candidate material or medical device,use of

a scaling factor is an important consideration when determin-

ing the relative size and/or surface area of sampled material

needed to exaggerate human dose/exposure for certain end-

points(e.g.,systemic toxicity,implantation,carcinogenicity).

The material surface area to body weight ratio and other

proportional parameters may be especially important for test-

ing porous materials and medical devices with repeated appli-

cations(e.g.,dialysis products).These also could be important

when assessing the potential risks of exposure to substances

released from a material over time,or exposure to degradation

products.

5.1.3 The first step in biological evaluation is to categorize

the medical device based on its intended tissue contact type

(refer to 5.2)and duration,which helps to facilitate the

9 The term “Iegally marketed device”and the necessary supporting biocompat-

iblity information may vary depending on the regulatory jurisdiction.

selection of relevant biological endpoints.The contact duration

can be divided into the following categories:

(1)Transitory contact(<1 min):very brief contact with the

body(e.g.,lancets,hypodermic needles,capillary tubes that are

used for less than one minute).Due to very brief contact time,

the risks in general are considered to be low,and testing may

not be needed.Note—Other terminology may exist for this

type of contact.

(2)Limited contact(≤24 h).

(3)Prolonged contact(24 h to 30 days).

(4)Long-term contact(>30 days).

5.1.3.1 When considering duration of contact for devices

that are intended for repeat use(e.g.,reusable devices or

single-use devices applied more than once to the patient during

treatment),cumulative exposure should also be considered and

applied to calculate the overall contact duration for use on a

single patient.The contact duration shall be based on the repeat

or cumulative use because,if chemicals are leached from the

device,those chemicals can bioaccumulate such that with

repeat medical device use,higher levels of chemicals may be

present in amounts that could result in adverse biological

response.Therefore,when determining the contact duration

categorization of repeat use devices,the total exposure period

in days of use of the medical device(e.g.,one medical device

can be reused intermittently over a number of days,or

replacement devices may be used over a number of days)on a

single patient should be considered,regardless of the duration

of exposure on each day.Cumulative or repeat use examples:

(1)Limited contact(≤24 h):

(A)A medical device used for three sessions within a

period of 24 h,20 min per session.

(B)A medical device used for 5 min,once every 30 days,

for a period of six months and there is specific information that

supports that bioaccumulation is unlikely(e.g.,elimination

time is less than one day).When utilizing this approach,it is

recommended to discuss the relevance of the available infor-

mation with the applicable regulatory body to determine the

appropriate contact duration.

(2)Prolonged contact(24 h to 30 days):

(A)A medical device used 20 min each day for five days.

(B)A medical device used for 5 min,once every 30 days,

for a period of six months and there is specific information that

supports that bioaccumulation is unlikely(e.g.,elimination

time is less than 30 days).When utilizing this approach,it is

recommended to discuss the relevance of the available infor-

mation with the applicable regulatory body to determine the

appropriate contact duration.

(3)Long-term contact(>30 days):A medical device used

for 5 min once a day for two months and information regarding

bioaccumulation is not available.

5.1.4 In general,the assessment for medical devices con-

taining biologically derived materials (e.g.,collagen based,

demineralized bone matrix,hyaluronic acid)or biologics

should address the same considerations specific to the type,

location,and duration of tissue contact as other medical

devices and products.Additional assessments for TEMPs are

provided in other standards (e.g.,ISO 22442)and may be

considered as part of an overall testing strategy.

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1ThisinternationalstandardwasdevelopedinaccordancewithinternationallyrecognizedprinciplesonstandardizationestablishedintheDecisiononPrinciplesfortheDevelopmentofInternationalStandards,GuidesandRecommendationsssuedbytheWorldTradeOrganizationTechnicalBarrierstoTrade(TBT)Committee.Designation:F748-25IN...

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