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D6362-98 – Standard Test Method Technical Guide
📑 Scope and Significance of D6362-98
ASTM D6362‑98 (Reapproved 2018) establishes a standardized practice for the information required on certificates of analysis for reference materials designated to support ASTM methods in water analysis. This practice provides end users with a defined set of data to evaluate material independence and suitability, while offering suppliers a consistent format for presenting certification data.
Per Section 1.2, all values stated in SI units are to be regarded as the standard. The practice was developed in accordance with internationally recognized principles on standardization established by the World Trade Organization Technical Barriers to Trade (TBT) Committee. It relies on terminology defined in ASTM D1129 and ISO Guide 30.
🟢 Key Benefit: This practice is specifically designed to ensure materials suitable for use as either calibration or quality control standards are available. It does not define a specific certification protocol, but rather provides guidance in the development of adequate data to support the material’s intended use.
📄 Certificate of Analysis Requirements
Section 5.1 states that the certificate of analysis must be a brief yet comprehensive summary allowing the potential user to assess suitability for their intended purpose. The use of terms defined by ISO or ASTM is mandatory, and suppliers must present analytical data and method information clearly and unambiguously.
The following table lists the key referenced documents that support the creation of a compliant certificate:
| 📜 Reference Document | 📝 Title / Focus Area |
|---|---|
| ASTM D1129 | Terminology Relating to Water |
| ASTM E826 | Practice for Testing Homogeneity of a Metal Lot or Batch in Solid Form by Spark Atomic Emission Spectrometry |
| ISO Guide 30 | Terms and Definitions Used in Connection with Reference Materials |
| ISO Guide 31 | Contents of Certificates of Reference Materials |
| ISO Guide 35 | Certification of Reference Materials—General and Statistical Principles |
| ISO/REMCO N280 | Related ISO Committee Document on Reference Materials |
Based on this standard and its referenced ISO Guides, the essential data elements for a certificate typically include:
| 🟦 Data Element | 🎯 Requirement |
|---|---|
| Material Identification | Unique lot or batch number and material name |
| Certified Values & Uncertainties | Best estimate of concentration and associated uncertainty |
| Method of Preparation | Details based on purity of raw materials and preparation method |
| Intended Use | Clear designation as a calibration or quality control standard |
| Traceability | Reference to NIST SRMs or other recognized standards |
| Expiration & Stability | Valid period for the certified values |
💡 Tip for Suppliers: When drafting your certificate, strictly adhere to the terminology defined in Section 3. The term “prepared value” is specifically defined as the best estimate of the concentration of a given analyte based upon the purity of raw materials and the method of preparation of the material.
📊 Significance of Consistent Presentation
The practice serves as a critical harmonizing tool for analytical laboratories. It ensures that reference materials are uniformly documented, which is essential for maintaining rigorous quality assurance protocols. End users are referred to ISO Guide 31 for a more complete description of the elements of typical certificates of analysis, while suppliers should refer to ISO Guide 35 for acceptable certification protocols.
❓ Frequently Asked Questions
🔍 What is the primary purpose of ASTM D6362?
Its primary purpose is to standardize the information required on certificates of analysis for reference materials used in water analysis, ensuring a consistent format for suppliers and a defined set of data for end users.
💡 Does this practice define a specific certification protocol?
No. Section 4.1 explicitly states it does not define a specific certification protocol. It provides guidance on the data outputs. Suppliers are referred to ISO Guide 35 for acceptable protocols.
⚡ What units are required by this standard?
Section 1.2 specifies that the values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.
📌 What is a “prepared value”?
As defined in Section 3.2.1, the prepared value is the best estimate of the concentration of a given analyte. It is based on the purity of raw materials and the method of preparation of the material.